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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: 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: ADJUVANT: ER/PR+: CDK4/6: NATALEE

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE

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Malignancy

Breast cancer, Invasive breast cancer, BC

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Aduvant

Investigational Agent

Ribociclib

Drug Class

CDK4/6 inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Path

ER or PR positive (HR+), adenocarcinoma

Key Eligibility Criteria Details
  • Histologically confirmed unilateral adenocarcinoma of the breast
  • Positive for ER and/or PgR
  • HER2 negative
  • Patient has had surgical resection where tumor was removed completely with negative margins
  • Anatomic Stage II or III
  • Completed neoadjuvant or adjuvant chemotherapy (if indicated)
  • Completed adjuvant XRT (if indicated)
  • Plan to treat pt with endocrine tx for 5 years
  • No prior CDK4/6 inhibitor
  • No prior tamoxifen, ralixofene, or AIs for chemoprevention
  • No prior tx with anthracycline at cumulative doses of 450mg/m2 or more
  • No distant metastatic disease
  • No other cancer within 2 years of study enrollment
  • No known HIV/HBV/HCV
  • No clinically significant cardiac disease
BREAST: Adjuvant: ER/PR+: HER2-; \"e3\"

Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of everolimus in patients with high-risk hormone receptor-positive and HER2/Neu negative breast cancer. E3 Breast cancer study- evaluating everolimus with endocrine therapy

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Malignancy

Breast, early breast cancer

Stage

Stage 2

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

N/A

Investigational Agent

everolimus

Drug Class

MTOR inhibitor

PI

Lee Schwartzberg, MD

Sponsor

Southwest Oncology Group

Path

Key Eligibility Criteria Details

High risk early breast cancer as defined as follows:

  • Post adjuvant chemo withTumor >2cm, N0, Oncotype Dx >25 or
  • Post adjuvantchemo with 1-3 positive nodes, OncDx >25 or
  • Post adjuvant chemo with >3 positive nodes or
  • Post neoadjuvant chemo with >3 positive nodes

HER2 negative, ER/PR positive
Completed standard neoadjuvant or adjuvant taxane or anthracycline therapy
No prior receipt of MTOR inhibitors
ECOG PS 0-2
Fasting cholesterol <300, TG <2.5x ULN
HIV positive allowed if controlled CD4 count and NOT on ART

BREAST: METASTATIC: TNBC: AKT/PIK3CA/PTEN: 1st Line: \"IPATunity130\"

A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (HR+ ARM CLOSED)

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Malignancy

Breast Cancer, MBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st line chemo

Investigational Agent

Ipatasertib

Drug Class

PI3 kinase inhibitor

PI

Greg Vidal, MD, PhD

Sponsor

Hoffman-La Roche

Path

Triple negative breast cancer

Key Eligibility Criteria Details
  • Triple negative cancer of the breast, locally advanced or metastatic not amenable to curative resection
  • ECOG PS 0-1
  • Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status by NGS
    • AKT1 missense mutations at E17, L52, or Q79
    • PIK3CA missense mutations at R88, G106, K111, G118, N345, C420, E453, E542, E545, Q546, M1043, H1047, or G1049
    • PTEN homozygous deletion, dominant negative short variant (C124S, G129E, or R130X), less of heterozygosity with copy number 1, double hit 
  • No known brain mets
  • No prior cancers within 5 years
  • No known HIV
  • No cirrhosis
  • No active steroid use (> or = 10mg prednisone/daily)
  • No clinically significant cardiac dysfunction including EF<50%
  • No insulin dependent diabetes
  • No Grade >=2 uncontrolled or untreated hyperlipidemia/hypertriglyceridemia
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: HER2+: Prior T-DM1: DESTINY-Breast02

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

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Malignancy

Breast Cancer, Invasive breast Cancer, BC, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line or 3rd line (prior T-DM1)

Investigational Agent

Trastuzumab deruxtecan (DS8201a)

Drug Class

HER-2 targeted ADC

PI

Greg Vidal, MD, PhD

Sponsor

Daiichi Sankyo, Inc.

Path

HER2 positive

Key Eligibility Criteria Details
  • Histologically confirmed unresectable or metastatic breast cancer
  • HER-2 positive (HER2+) by ASCO-CAP guidelines and confirmed by central lab
  • Previously treated with T-DM1
  • Progression following last treatment (cannot go on after stopping treatment for toxicity alone)
  • No prior capecitabine
  • No history of insterstitial lung disease or pneumonitis requiring steroids
  • No active CNS disease
BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: EMERALD

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

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Malignancy

Breast, invasive breast cancer, IBC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line (post CDK4/6 inh)

Investigational Agent

Elacestrant

Drug Class

Selective Estrogen Receptor Degrader (SERD)

PI

Greg Vidal, MD, PhD

Sponsor

Radius Pharmaceuticals, Inc.

Path

adenocarcinoma, ER/PR +, HER2-

Key Eligibility Criteria Details
  • Subjects with adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or XRT, or metastatic disease
  • Must be appropriate candidates for endocrine monotherapy
  • Either measurable disease or bone-only (nonmeasurable) disease
  • Post-menopausal women or men
  • Must be ER+, HER2 -
  • Must have received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer
  • Must have received prior treatment with CDK4/6 inhibitor in combination with either fulvestrant or an AI
  • No more than one line of chemotherapy in the advanced/metastic setting
  • No prior treatment with investigational SERD or ER antagonist
  • No presence of symptomatic visceral disease
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
  •  
BREAST: METASTATIC: ER/PR+: HER2 neg: No prior taxane: CONTESSA 2

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

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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

1st line chemo (most likely)

Investigational Agent

tesetaxel

Drug Class

oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER/PR positive, HER2 negative

Key Eligibility Criteria Details
  • Pathologically confirmed locally advanced unresectable or metastatic breast cancer
  • HER2 negative (-) disease
  • Hormone receptor (ER and/or PR) positive (+)
  • Measurable disease
  • CNS disease is allowed provided that patient is neurologically stable on maximum dose of 4mg dexamethosone, no leptomeningeal disease, and no local-directed CNS treatmnt is immediately necessary
  • ECOG PS 0-2
  • No limit on number of prior endocrine therapies
  • No more than 2 prior lines of chemotherapy
  • No prior treatment with either capecitabine or any taxane
  • No other malignancies within 5 years except with discussion with medical monitor
  • No HIV, HBV, HCV
  • No Grade 2 or higher neuropathy
  •  
BREAST: METASTATIC: HER2 negative: 1st Line: Older Adults: CONTESSA TRIO >65

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

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Malignancy

Breast, Metastatic Breast Cancer, MBC,

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line Chemo

Investigational Agent

Tesetaxel

Drug Class

Oral taxane

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

HER2 negative (Any ER or PR status)

Key Eligibility Criteria Details
  • Age 65 or older
  • Locally advanced breast cancer not considered curable by surgery or radioation or metastatic breast cancer
  • Measurable Disease
  • Brain mets are allowed
  • ECOG PS 0-2
  • If ER/PR+, must have received prior therapy with endocrine therapy (+/- CDK 4/6 therapy).
  • Any number of prior endocrine or targeted therapies are permitted
  • No prior chemotherapy for metastatic disease
  • No known HIV/HBV/HCV
  • No Grade >1 neuropathy
BREAST: METASTATIC: TNBC: 1st Line: CONTESSA TRIO

A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC

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Malignancy

Breast cancer, triple-negative breast cancer, TNBC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Tesetaxel, nivolumab, pembrolizumab, atezolizumab

Drug Class

oral taxane, PD-1 or PD-L1 inhibitors

PI

Lee Schwartzberg, MD

Sponsor

Odonate Therapeutics, Inc.

Path

ER negative, PR negative, HER2 negative

Key Eligibility Criteria Details
  • ER -, PR-, HER2 - biopsy proven breast cancer
  • Locally advanced (not curable by surgery or radiation) or metastatic
  • No prior chemotherapy for metastatic disease
  • (Neo)Adjuvant therapy allowed if disease free interval of at least 12 months after completion
  • No prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors
  • Tissue available for PD-1 level determination
  • ECOG PS 0-2
  • No known HIV/HBV/HCV
  • No history of active autoimmune disease
  • No Grade 2 or higher neuropathy
BREAST; METASTATIC: PHASE 1 (EXPANSION): TRIPLE NEGATIVE: 2nd 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
  • 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: METASTATIC: ER/PR+: 3rd Line or later: Sacituzumab: IMMU-132-09

Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens

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Malignancy

Breast, ER positive breast cancer, MBC, PR positive breast cancer, HER2 negative breast cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd Line or greater

Investigational Agent

Sacituzumab govitecan

Drug Class

ADC for Trop-2

PI

Lee Schwartzberg, MD

Sponsor

Immunomedics, Inc

Path

ER/PR +, HER2-

Key Eligibility Criteria Details
  • Hormone receptor positive, HER2 negative metastatic breast cancer
  • Refractory to or relapsed after at least 2, and no more than 4, prior systemic therapies including;
    • At least 1 prior anticancer hormonal treatment
    • At least 1 CDK4/6 in the metastatic settting
  • Eligible to receive at least 1 of the following chemotherapies; eribulin, capecitabine, gemcitabine, vinorelbine
  • Disease progression after most recent therapy
  • No potential therapy available with curative intent (e.g. surgery)
  • No prior Topo1 inhibitors
MOLECULARLY TARGETED: TMB-high: >/=2nd Line: MY PATHWAY- TMB

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

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Malignancy

Breast cancer, Endometrial, Uterine, Ovarian, Cervical, Colon, colorectal, biliary, gastric, esophageal, sarcoma, pancreatic, bladder, prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2ndline or later

Investigational Agent

Atezolizumab

Drug Class

PD-L1 inhibitor

PI

Ari VanderWalde, MD

Sponsor

Genentech

Path

Solid tumor

Key Eligibility Criteria Details
  • PD-L1 copy number gain/amplification (likely available on Foundation only)
  • Patients with MSI-high
    • Using either Foundation 1 or other NGS defined by a shift in the size of 30% or more loci
  • Patients with dMMR
    • Defined as loss of at least one of four markers (MLH1, MSH2, PMS2, MSH6)
  • Patients with total mutational burden (TMB) high
    • 10 mut/Mb per any CLIA certified test
  • Patients with alterations in DNA proofreading/repair genes
    • POLE mutations
    • POLD1 mutations
    • Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
  • If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
  • No metastatic non-small cell lung cancer (no NSCLC)
  • No metastatic urothelial carcinoma (no bladder cancer)
  • No MSI-high colorectal cancer
  • No history of autoimmune disease or immune deficiency
  • No HIV/HBV/HCV
  • No other malignancy within 5 years
  • No need for immunosuppressive medications (including steroids)
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
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
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