West Cancer Center

BREAST: NEOADJUVANT: ER+: Post-menopausal: DOD 16-1042

Randomized phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/HER2- breast cancer

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Malignancy

Breast cancer, Hormone receptor positive breast cancer, locally advanced BC

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

Enzalutamide and fulvestrant

Drug Class

Androgen receptor inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

University of Colorado, Department of Defense

Path

ER positive, HER2 negative

Key Eligibility Criteria Details

ER positive breast cancer
Tumor stage at least T2
Plan to receive local surgery
Post-menopausal or if premenopausal will need to have concurrent ovarian suppression
ECOG PS 0-2
No history of seizures
Not on full dose anticoagulation
No prior treatment with anti-androgen agents
No history of CNS metastases

BREAST: NEOADJUVANT: Triple Negative: BIOMARKER SPECIFIC: FACT-2

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

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Malignancy

Breast, Triple Negative Breast Cancer

Stage

Stage 2

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Neoadjuvant

Investigational Agent

Neratinib

Drug Class

HER2 targeted small molecule

PI

Greg Vidal, MD, PhD

Sponsor

West Cancer Center, Puma Biotechnology, Celcuity

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details

T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
ER/PR <10%, HER2 negative
ECOG PS 0-1
ANC >1200, Hgb >10, Plt >100,000
Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
No T3 or T4 tumors
No definitive surgical treatment performed yet
No evidence of metastatic disease
No prior history of ipsilateral DCIS or breast cancer
No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
No other malignancies within 2 years prior
No active cardiac disease
No uncontrolled hypertension
No known HIV/HBV/HCV
No neuropathy grade >=2

Breast: Post-Mastectomy: Hypofractionated Radiotherapy: RT CHARM

RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

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Malignancy

Breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Adjuvant

Investigational Agent

Hypofractionated radiotherapy

Drug Class

Radiation

PI

Noam VanderWalde, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Invasive ductal, invasive lobular, tubular

Key Eligibility Criteria Details

Invasive breast cancer (ductal, lobular, tubular, mammary, medullary)
If received neoadjuvant therapy, pre treatment staging must have N1 or N2 disease pre-chemo or are T3N0
If did not receive neoadjuvant, must be T0N1-2a, T1N1-2a, T2N1-2a, or T3N0-2a.
No prior therapeutic radiation to the chest, neck, or axilla
No prior history of ipsilateral breast cancer
- DCIS or LCIS are allowed
Negative margins following mastectomy
No significant post mastectomy complications in the ipsilateral breast requiring unplanned re-operation or admission for IV antibiotics.
- Reoperation for margins or lymph node dissection is allowed
Radiation oncologist is NOT planning to use a chest wall/scar boost
Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
No co-existing medical conditions with a life expectancy <5 years
ECOG PS 0-1

BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; axillary dissection vs XRT; “Alliance-011202”

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

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Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

N/A

Drug Class

N/A

PI

Richard Fine, MD

Sponsor

Alliance for Clinical Trials in Oncology

Path

Node-positive any histology

Key Eligibility Criteria Details

Stage T1-3 N1 M0 at diagnosis (prior to start of neoadjuvant chemotherapy)
No inflammatory breast cancer
No other malignancy within 5 years
Must have received axillary ultrasound with bx or axillary lymph nodes prior to or within 14 days of starting neoadjuvant therapy
Must have documented ER/PR/HER2 status before neoadjuvant therapy
Must have completed all planned chemotherapy prior to trial (ie. no planned adjuvant therapy)
Must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane based regimen
HER2 positive patients must have received anti-HER2 therapy as part of neoadjuvant regimen
Must have clinically negative axilla documented on physical exam at the completion of neoadjuvant chemotherapy (no imaging needed)
No neoadjuvant endocrine or radiation therapy
No history of prior breast cancer
ECOG PS 0-1
Must complete surgery within 56 days of finish of neoadjuvant therapy
At least 1 sentinel lymph node identified intra-operatively with at least micromets

BREAST: EARLY BREAST CANCER: Prior neo-adjuvant; standard vs comprehensive XRT; “NSABP B-51"

A randomized phase III clinical trial evaluating post-mastectomy chestwall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy VIEW TRIAL ON CLINICALTRIALS.GOV

Malignancy

Breast Cancer, Early Breast Cancer, Node-positive breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to enrollment

Line Of Therapy

Post-neoadjuvant

Investigational Agent

regional nodal irradiation

Drug Class

N/A

PI

Noam VanderWalde, MD

Sponsor

NSABP Foundation

Path

Node positive prior to surgery, pathologically node negative at surgery

Key Eligibility Criteria Details

Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma). Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).
Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)
Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.
HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)
Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen
For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer
ECOG PS 0-1

BREAST: Metastatic: ER+, HER2neg, 1st line: BO41843

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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Malignancy

Breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line (pre-chemo)

Investigational Agent

GDC-9545

Drug Class

Selective estrogen receptor degrader (SERD)

PI

Greg Vidal, MD, PhD

Sponsor

Hoffmann-LaRoche

Path

ER+ (positive), HER2 - (negative)

Key Eligibility Criteria Details

Postmenopausal or pre-menopausal but treated with LHRH agonist therapy for the duration of study treatment
Locally advanced or metastatic adenocarcinoma of the breast not curable
Documented ER-positive and HER2-negative
No prior systemic anti-cancer therapy for metastatic disease
Measurable disease
ECOG PS 0-1
No disease recurrence within 12 months of treatment with an AI or a CDK4/6 inhibitor in adjuvant/neoadjuvant setting
No prior SERD
No active CNS disease

BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 1st Line: MORPHEUS

A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo

Drug Class

PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

ER- (negative), PR- (negative), HER2- (negative)

Key Eligibility Criteria Details

Triple negative metastatic breast cancer
2nd line
ECOG PS 0-2
No prior treatment with any study agents
No history of autoimmune disease
Presence of measurable disease
No symptomatic or untreated CNS disease

BREAST: TNBC: HMGA2 high(prescreening): > or = 2nd line: MS200647_0020: :

A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

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Malignancy

Breast, triple negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

Bintrafusp alfa

Drug Class

Bifunctional fusion protein, anti-PD-L1 + TGF-beta trap

PI

Greg Vidal, MD, PhD

Sponsor

EMD Serono Research and Development Institute

Path

ER - (negative), PR - (negative), HER2 - (negative), HMGA2 overexpressing

Key Eligibility Criteria Details

Histologically or cytologically confirmed TNBC
At least 1 line of systemic therapy for metastaic disease and have progressed on line of therapy immediately prior to study entry
May screen for HMGA2 during preceding treatment, but should only occur if MD thinks progression will occur within 6 months
Measurable disease
Availability of archival tumor tissue, fresh core, or excisional biopsy to determine HMGA2 expression prior to enrollment
ECOG PS 0-1
HIV, HBV, HCV are eligible
No active CNS metastases causing clinical symptoms
No prior immunotherapy or checkpoint inhibitor therapy
No active autoimmune disease

BREAST: METASTATIC: TNBC: PHASE 1: 2nd/3rd LINE: MK-5890-01-ARM2A

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

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Malignancy

Breast, Triple Negative Breast Cancer, TNBC

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd or 3rd line

Investigational Agent

MK-5890

Drug Class

CD27 agonist

PI

Dan Vaena, MD

Sponsor

Merck Sharp & Dohme Corp

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details

Must have measurable disease by RECIST 1.1
Diagnosis of TNBC
Must have received or been intolerant to not more than 2 lines of therapy for metastatic disease
Prior therapy should have included anthracycline and/or taxane
LDH must be <2x ULN at screening
May be PD-L1 treatment refractory (number capped)
ECOG PS 0-1
No 2nd malignancy within 2 years
No active CNS involvement
No history of interstitial lung disease
No active pneumonitis or history of non-infectious pneumonitis that required steroids
No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
No known HIV, HBV, HCV
No need for steroids at dose of greater than 10mg prednisone or equivalent daily
No recent history of substance abuse

BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: ESR1 mutant: SMX 18001

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation

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Malignancy

Breast cancer, invasive breast cancer, BC, hormone receptor positive BC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line or later endocrine tx

Investigational Agent

Lasofoxifene

Drug Class

SERM

PI

Lee Schwartzberg, MD

Sponsor

Sermonix Pharmaceuticals LLC

Path

ER positive, HER2 negative

Key Eligibility Criteria Details

Postmenopausal women with locally advanced or metastatic breast cancer
Progression on an aromatase inhibitor (AI) in combination with a CDK4/6 inhibitor
Demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in metastatic setting)
Measurable or non-measurable disease allowed
One of the following ESR point mutations in cell-free DNA:
- Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N
May have received up to one chemothearpy regimen in adjuvant or neoadjuvant setting
ECOG PS 0-1
No prior use of any SERM with following exception
- OK if tamoxifen previously used in adjuvant setting with relapse at least 1 year after stopping tamoxifen
No prior everolimus or PI3K inhibitors
No presence of CNS disease
No immediate need for chemotherapy
No HIV, HBV, HCV
No prior malignancy in last 5 years except non-melanoma skin cancer or early stage cervical cancer
No uncontrolled HTN

SUPPORTIVE CARE: DIARRHEA PROPHYLAXIS: ON TARGETED THERAPY: ON-TARGET

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

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Malignancy

Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

Crofelemer

Drug Class

Botanical oligomeric proanthocyanidin

PI

Lee Schwartzberg, MD

Sponsor

Napo Pharmaceuticals

Path

Any

Key Eligibility Criteria Details

Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
- CDK4/6 inhibitors (abemaciclib),
- PI3 kinase blockers (alpelisib),
- anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib)
- anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
- anti ALK TKIs (ceritinib, crizotinib)
- MEK inhibitor (cobimetinib)
- Anti HER2 TKIs (lapatinib, tucatinib)
ECOG PS 0-2
Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
No diarrhea before enrolling on the study (or starting TKI)
No ongoing IBS or colitis
Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
No laxative use within 7 days prior to randomization

MOLECULARLY TARGETED: ROS1 fusion: myTACTIC Arm A

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Ideally 1st line, but can be later line as well

Investigational Agent

Entrectinib

Drug Class

TKI against NTRK, ROS, and ALK

PI

Sponsor

Genentech, Inc.

Path

ROS1 fusion. Any cancer type except not NSCLC

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
ROS1 gene fusion positivity
No non-small lung cancer (NSCLC)
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib

MOLECULARLY TARGETED: ALK Rearrangement: myTACTIC Arm C

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmC: Alectinib in patients with ALK rearrangement-positive tumors

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Malignancy

Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Alectinib

Drug Class

ALK and RET inhibitor

PI

Sponsor

Genentech, Inc.

Path

ALK rearrangement/fusion in any malignancy except not NSCLC

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
Not Non-small cell lung cancer (NO NSCLC)
ALK gene fusion positivety defined as a 3' AALK fusion with a protein coding 5' gene fusion partner, predicted to be in frame with an intact kinase domain
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib

MOLECULARLY TARGETED: PTEN loss/LOF: myTACTIC Arm D(1)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Sponsor

Genentech, Inc.

Path

PTEN loss or loss of function

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
Either PTEN protein loss as determined by a CLIA or equivalently certified immunohistochemistry assay OR
PTEN loss of function defined as PTEN dominant negative missense mutations or deleterious in-frame and missense mutations affecting protein function
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib
No insuline dependent diabetes

MOLECULARLY TARGETED: AKT mutation: myTACTIC Arm D(2)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Sponsor

Genentech, Inc.

Path

select AKT mutations

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
One of the following mutations in AKT:
- AKT 1 : E17K, L52R, or Q79K
- AKT 2 : E17K
- AKT 3: E17K, L51R, or Q78K
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib
No insulin dependent diabetes

MOLECULARLY TARGETED: TMB high: myTACTIC Arm E(1)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line but cannot have previously had PD-1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Sponsor

Genentech, Inc.

Path

TMB high, defined as > or = 10 mutations/megabase

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
Tumor mutational burden-high (TMB-H) determined by CLIA opr quivalently certified assay, via tissue or blood
No prior treatment with anti-PD1 or anti-PD-L1 agents
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib
No active autoimmune disease

MOLECULARLY TARGETED: MSI-h/dMMR: myTACTIC Arm E(2)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior anti-PD-1 or anti-PD-L1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Sponsor

Genentech, Inc.

Path

MSI-h or dMMR

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
Microsatellite instability high (MSI-h) or deficient mismatch repair dMMR
No prior treatment with anti-PD1 or anti-PD-L1 agents
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No prior treatment with crizotinib
No active autoimmune disease

MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification

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Malignancy

Bladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Path

HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer

Key Eligibility Criteria Details

Histologically confirmed cancer for which no curative therapy exists
Documented HER2 (ERBB2) or HER4 (ERBB4) mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
- Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
At least one measurable or evaluable lesion
LVEF >/=50%
ECOG PS 0-2
No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
No symptomatic or unstable brain mets (stable are allowed)
No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
No uncontrolled cardiac disease
No chronic diarrheal disorder

ADVANCED SOLID TUMORS: PHASE 1: ENDOMETRIAL, OVARIAN, Or PVRL2: CPG-03-101

A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

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Malignancy

Endometrial, Ovarian, Breast, Lung, Colon, Prostate, Gastric, Esophageal, Cervical, Melanoma, Skin, Pancreas, Pancreatic, Sarcoma, Head and Neck (HNPCC), NSCLC, SCLC, Kidney, Bladder, RCC, Prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line (post standard therapy)

Investigational Agent

COM-701, BMS-986207, nivolumab

Drug Class

PVRIG antagonist, anti-TIGIT Ab, PD-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen, Ltd

Path

PVRL2 high (only for basket cohort)

Key Eligibility Criteria Details

Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or not a candidate for standard therapy
ECOG PS 0-1
Prior therapy with immune therapy are eligible (except in ovarian cohort)
In Expansion cohorts patients must either have
- Advanced epithelial cancer of the ovary, fallopian tube, or peritoneum
- Advanced MSS endometrial cancer
- A different malignancy that has high expression of PVRL2
No active autoimmune disease
No interstitial lung disease
No active CNS metastases
In ovaran cohort, no prior immunotherapy
No prior therapy with PVRIG inhibitor or anti-TIGIT antibody

ADVANCED SOLID TUMORS: PHASE 1: OBI-888

A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

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Malignancy

Colon, Ovarian, Gastric, Pancreatic, Endometrial, lung, prostate, breast

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-888

Drug Class

Anti-globo-H antibody

PI

Sponsor

OBI Pharma

Path

Globo-H overexpression

Key Eligibility Criteria Details

Histologically or cytologically confirmed patients with advanced or metastatic solid tumors
Measurable disease
Must have been treated with all estrablished standard-of-care therapy or determined by the physician that such established therapy is not sufficiently efficacious, or patients have declined to receive standard of care therapy
ECOG PS 0-1
Must have Globo-H overexpression as measured by central lab
No known active autoimmune or inflammatory disease
Not receiving systemic steroids of >10mg prednisone per day or equivalent

ADVANCED TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-001

Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies

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Malignancy

Lung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Any line as long as appropriate to give study acceptable chemo in combination

Investigational Agent

TTX-030

Drug Class

anti CD-39

PI

Dan Vaena, MD

Sponsor

Trishula Therapeutics, Inc.

Path

Any malignancy

Key Eligibility Criteria Details

Advanced solid tumor or relapsed/refractory lymphoma OR
- eligible to receive single agent pembrolizumab as standard-of-care OR
- eligible to receive single-agent docetaxel as standard of care OR
  advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care
Measurable disease
ECOG PS 0-1
No history of severe autoimmune disease
Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy

METASTATIC SOLID TUMORS: PHASE 1 (ESCALATION): PVRIG+PD-1: CPG-01-001

A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.

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Malignancy

Ovarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

COM-701, PD(L)-1 antibody

Drug Class

PVRIG monoclonal antibody, PD(L)-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen

Path

Key Eligibility Criteria Details

Histologically or cytologically confirmed, metastatic solid malignancy
Has exhausted all available standard therapy or not a candidate for standard therapy
ECOG PS 0-1
Prior PD-1/PD-L1 allowed
No other malignancy within 2 years prior
No active autoimmune disease requiring systemic therapy within last 2 years
No chronic steroids or immunosuppressants.

ADVANCED TUMORS: PHASE 1 (ESCALATION): PD-1 naive or experienced; TIM3+NIVOLUMAB: CA031002

A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors

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Malignancy

Renal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

BMS 986258

Drug Class

TIM-3 antibody

PI

Dan Vaena, MD

Sponsor

Bristol Myers Squibb

Path

Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any

Key Eligibility Criteria Details

ECOG PS 0-1
No active CNS disease (controlled brain mets are allowed)
Must have one of the five malignancies below
- Clear-cell RCC
- Triple-negative Breast Cancer
- Squamous cell carcinoma of the head and neck
- Colorectal cancer
- Non-small cell lung cancer
No other malignancies within 2 years
No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
No severe autoimmune reactions to immunotherapy
No need for active steroid therapy
No significant cardiac disease
No chronic hepatitis
No active interstitial lung disease
RCC specific eligibility criteria
- Previously received one or two anti-VEGFR therapies
- No more than 3 total prior systemic tx in metastatic setting
- Must have evidence of progression on or after last treatment received and within 6 months of starting study
CRC specific eligibilty criteria
- Must have received and progressed on at least 1 standard therapy for metastatic disease
- Must have known MSI status
NSCLC specific eligibility criteria
- Must have progressed on or been refractory to platinum doublet
- Must have known EGFR, ALK, ROS1 status.
  - Those with EGFR or ALK alterations must have previously received TKI therapy
SCCHN specific eligibility criteria
- Not amenable ot local therapy with curative intent
- Must have progressed on or been intolerant of platinum containing regimen
TNBC specific eligibility criteria
- Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane