West Cancer Center

BILIARY TRACT: METASTATIC: 1st Line: SWOG S1815

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

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Malignancy

Biliary Tract, cholangiocarcinoma, gallbladder cancer, bile duct cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

nab-paclitaxel

Drug Class

taxane

PI

Axel Grothey, MD

Sponsor

Southwest Oncology Group (SWOG)

Path

biliary carcinoma

Key Eligibility Criteria Details

Histologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer
Must have metastatic or unresectable disease and no prior therapy for metastatic disease
Does not need to be measurable disease
No ampullary cancer
No adjuvant therapy within 6 months prior to registration
ECOG PS 0-1
No other prior malignancy within 2 years

BILIARY TRACT: METASTATIC: 2nd Line: LEAP-005-Biliary

A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)

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Malignancy

Biliary Tract Cancer, Cholangiocarcinoma; Gallbladder cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd Line

Investigational Agent

Lenvatinib and Pembrolizumab

Drug Class

VEGF-R/FGFR inhibitor and PD-1 inhibitor

PI

Manjari Pandey, MD

Sponsor

Merck Sharp & Dohme Corp

Path

Adenocarcinoma

Key Eligibility Criteria Details

Biliary Tract Cancer with 1 prior line of therapy
Adjuvant therapy only counts as prior line if recurrence within 6 months of completing tx
Measurable Disease per RECIST 1.1
Archival tissue or newly obtained tissue available
ECOG PS 0-1
BP < or = 150/90 at screening without change in antihypertensives within 1 week before C1D1
No evidence of malabsorption syndrome
No evidence of major blood vessel involvement
No clinically significant hemoptysis or tumor bleeding
No arterial thromboembolism within 12 months
No significant CAD within 12 months
No prior lenvatinib or checkpoint inhibitor therapy
Prior bevacizumab is allowed
No proteinuria defined as Uprotein >1g/24 hours
LVEF must be 55% or greater
No chronic systemic steroid or immunosuppressive therapy
No diagnosis of immunodeficiency
No active CNS metastases
No tumor involving the brain stem
No active autoimmune disease that has required treatment within last 2 years
No known HIV/HBV/HCV

BLADDER: Metastatic: 1st line: Cisplatin Ineligible: HCRN GU15-215

A Randomized Phase II Trial of Atezolizumab With or Without Bevacizumab in Cisplatin-ineligible Patients With Advanced/Unresectable Urothelial Cancer: Hoosier Cancer Research Network GU15-215

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Malignancy

Bladder, Transitional Cell, Ureter, Urethral, Renal Pelvis, Urothelial

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Atezolizumab and Bevacizumab

Drug Class

PD-L1 Antibody; VEGFR Antibody

PI

Dan Vaena, MD

Sponsor

Hoosier Cancer Research Network

Path

Transitional Cell Carcinoma

Key Eligibility Criteria Details

ECOG PS 0-2
Histological or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra
Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease
Evaluable untreated tumor tissue for biomarker analysis.
Willing to undergo a core needle or excisional biopsy on-treatment.
Measurable disease
No prior chemotherapy for locally advanced or metastatic urothelial cancer
- Perioperative chemotherapy previously administered in the neoadjuvant and/or adjuvant setting is permitted
Ineligible for cisplatin as defined by presence of one or more of the following:
- Impaired renal function [GFR ≥ 30 but ≤ 60 cc/min].
- Grade ≥ 2 Hearing Loss (hearing loss measured by audiometry of 25 dB at two contiguous frequencies)
- Grade ≥ 2 peripheral neuropathy
- ECOG Performance Status of 2
- Solitary Kidney
No Active or untreated central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
- Evaluable or measurable disease outside the CNS
- No metastases to midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
- No history of intracranial or spinal cord hemorrhage
- No evidence of significant vasogenic edema
- No ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dose allowed
- No stereotactic radiation, whole-brain radiation within 4 weeks prior to Cycle 1 Day 1
- Patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy within 3 months prior to Cycle 1 Day 1 will be excluded
No malignancies other than urothelial cancer within 5 years prior
No history of autoimmune disease
Known HIV, HBV, or HCV
No inadequately controlled hypertension (defined as persistent systolic blood pressure (SBP) > 150 and/or diastolic blood pressure (DBP) > 100 mmHg)

BLADDER: METASTATIC: FIRST LINE: IMMUNOCHEMO COMB: NILE

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

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Malignancy

Bladder Cancer, Urothelial Cancer, Transitional Cell Carcinoma, Ureter, Renal Pelvis

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Durvalumab, Tremelimumab

Drug Class

PD-L1 antibody, CTLA-4 antibody

PI

Dan Vaena, MD

Sponsor

AstraZeneca

Path

Transitional cell carcinoma

Key Eligibility Criteria Details

Unresectable or metastatic transitional cell carcinoma or the urothelium (renal pelvis, ureters, urinary bladder, or urethra)
- Both transitional cell and mixed transitional/non-transitional cell histologies are permitted
No prior 1st line therapy for metastatic disease
- Prior adjuvant therapy allowed if it has been >12 months since last therapy
- Prior local intervesical chemo or immune therapy is allowed if at least 28 days before study treatment
Either cisplatin-eligible or cisplatin-ineligible but carboplatin eligible patients are allowed
Measurable disease
ECOG PS 0-1
No prior immunotherapy with exception of BCG or antitumor vaccines
No autoimmune disease requiring immunosuppression
No untreated CNS disease
No contraindications to platinum-based doublet chemotherapy

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 (combimetinib)
- 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

Axel Grothey, MD

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: PIK3CA Mutations: myTACTIC Arm B

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: ArmB: GDC-0077 in patients with PI3K activating mutation-positive tumors

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Malignancy

Breast, Lung (NSCLC), 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

GDC-0077

Drug Class

PI3K p110 alpha inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

PIK3CA mutation positive. Any malignancy except NOT CNS tumors

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
No primary CNS malignancy
One of the following PIK3CA mutations:
- R88Q
- G106A/D/R/S/V
- K111N/R/E
- G118D
- N345D/H/I/K/S/T/Y
- C420R
- E453A/D/G/K/Q/R/V
- E542A/D/G/K/Q/R/V
- E545A/D/G/K/L/Q/R/V
- Q546E/H/L/P/R
- M1043I/T/V
- H1047D/I/L/M/P/Q/R/T/Y
- G1049A/C/D/R/S
- Others only with study medical monitor approval
ECOG PS 0-2
No symptomatic CNS metastases
No known HIV/HBV/HCV
No other malignancy within 3 years of study
No anti-hyperglycemic medication (no treated T2DM or T1DM)

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

Axel Grothey, MD

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

Axel Grothey, MD

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

Axel Grothey, MD

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

Axel Grothey, MD

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

Axel Grothey, MD

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: HER2/ERBB2 amplification or mutation: myTACTIC Arms F/G/H/I

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm F: Trastuzumab emtansine plus atezolizumab Arm G: PH FDC SC Arm H: PH FDC SC plus chemotherapy Arm I: trastuzumab emtansine plus tucatinib, in patients with ERBB2 gene amplification- or mutation-positive tumors.

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Malignancy

Lung, 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

Investigational Agent

TDM-1 with atezolizumab, or PH FDC SC with or without chemotherapy, or TDM-1 with tucatinib

Drug Class

Anti-HER2 agents

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB2 amplification or specific mutation

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
No breast cancer (breast cancer is excluded)
Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
Any of the following ERBB2 mutations:
- 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896CG
TMB must be <10 mutations/megabase
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: HER2/ERBB2 amp or mut; TMB-h: myTACTIC Arm J

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm J: Trastuzumab emtansine plus atezolizumab in patients with ERBB2 amplification or mutation plus TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Lung, 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

TD-M1 + atezolizumab

Drug Class

anti-HER2 agent and anti-PD-L1 agent

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB amplificaiton or mutation AND TMB-h or 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
No breast cancer (breast cancer is excluded)
Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
Any of the following ERBB2 mutations:
- 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896CG
Must ALSO have one of the following alterations
- TMB > or =10 mutations/megabase
- MSI-h
- dMMR (negative IHC for MLH1, MSH2, MSH6, or PMS2_
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: FGFR-mutant or fusions: FGFR inhibitor: FIGHT-207

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

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Malignancy

Solid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Following all effecive therapy (late line)

Investigational Agent

Pemigatinib

Drug Class

FGFR inhibitor

PI

Dan Vaena, MD

Sponsor

Incyte Corporation

Path

FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation

Key Eligibility Criteria Details

Metastatic or surgically unresectable solid tumor
Measurable disease
Documentation of an FGFR1-3 gene mutation or translocation
At least 1 prior line of therapy with progression
No other therapy available likely to provide clinical benefit
ECOG PS 0-2
No other FGFR inhibitors within last 6 months
No clinically significant corneal or retinal disorder
No untreated CNS disease (except primary brain cancer)
No additional malignancy at current time requiring active treatment
No history of calcium or phosphate disorder or systemic mineral imbalance
No clinically significant cardiac disease
No active HBV/HCV
No known HIV

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: CTL WT1 inducers: DSP7888-102CI

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

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Malignancy

Urothelial Neoplasm, Bladder Cancer, Renal Cell Carcinoma, Head and Neck, Lung Cancer, NSCLC, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Cervical Cancer, Melanoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

DSP-7888

Drug Class

peptide vaccine stimulating cytotoxic T-cells expressing WT1

PI

Dan Vaena, MD

Sponsor

Sumitomo Dainippon Pharma Oncology Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
Must not be eligible for curative resection
Must be positive for at least 1 of the following human leukocyte antigens:
- HLA-A*02:01
- HLA-A*02:06
- HLA-A*24:02
- HLA-A*03:01
- HLA-B*15:01
ECOG PS 0-1
No known CNS mets
No known HIV/HBV/HCV

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.

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