West Cancer Center

ENDOMETRIAL: ANY STAGE: ADJUVANT: CHEMO-NAIVE: HER2+: NRG-GY026

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Malignancy

Endometrial, uterine

Stage

Stage 3

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Trastuzumab or trastuzumab/pertuzumab

Drug Class

HER2 antibody

PI

Todd Tillmanns, MD

Sponsor

NRG Oncology

Path

Serous carcinoma or carcinosarcoma

Key Eligibility Criteria Details

FIGO 2009 stage IA-IVB non-recurrent, chemo-naive, HER2-positive endometrial serous carcinoma or carcinosarcoma
Measurable or no-measurable disease allowed
ECOG PS 0-2
No prior chemo, biologic therapy, or targeted thearpy for treatment of endometrial cancer
No prior radiation therapy for endometrial cancer
No planned radiation
No significant cardiac, lung, or intercurrent illness
Patients with prior treatment with hormonal therapy are allowed

LUNG: NSCLC: METASTATIC: 1st LINE: R3767-ONC-2236

A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

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Malignancy

Lung Cancer, Non-small cell lung cancer, NSCLC

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Fianlimab

Drug Class

Anti-LAG-3 antibody

PI

Jason Porter, MD

Sponsor

Regeneron Pharmaceuticals

Path

Non-small cell lung cancer

Key Eligibility Criteria Details

Metastatic or Stage IIIB or C unresectable non-small cell lung cancer
Availble PD-L1 results
Measurable disease
ECOG PS 0-1
No active CNS disease
Negative for EGFR mutations or ALK or ROS fusions
No history of insterstitial lung disease except resolved radiation pneumonitis
No autoimmune disease except hyopthyroidism
Cannot require corticosteroid treatment >10mg prednisone daily
May have received adjuvant or neoadjuvant therapy with platinum doublets, anti-PD1 with or without LAG-3, or CTLA-4, as long as greater than 6-12 months before enrollment (time off depends on the agent)

LUNG: NSCLC: 1st Line: KRAS G12C mt: KRYSTAL-7

A Phase 2 Trial of MRTX849 in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

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Malignancy

Non small cell lung cancer (NSCLC)

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

MRTX849 (adagrasib), Pembrolizumab

Drug Class

KRAS G12C inhibitor, PD-1 inhibitor

PI

Jason Porter, MD

Sponsor

Mirati Therapeutics Inc.

Path

Non-small cell lung cancer, KRAS G12C mutation

Key Eligibility Criteria Details

Histologically confirmed diagnosis of metastatic or unresectable NSCLC (squamous or nonsquamous) not a candidate for definitive therapy
KRAS G12C mutation
Known PD-L1 status (can enroll regardless of level)
1st line- no prior treatment for metastatic NSCLC
- OK to have had radiosensitizing chemo >1 year prior
ECOG PS 0-1
Measurable disease
No active CNS mets
No XRT to the lungs within 6 months prior to first dose of study treatment
No known autimmune disease

ADVANCED SOLID TUMORS: METASTATIC: TSC1/TSC2 alterations: last line: PRECISION 1

A Phase 2 Multi-center Open-label Basket Trial of Nab-sirolimus for Adult and Adolescent Patients With Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes.

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Malignancy

Breast, lung, colon, prostate, bladder, RCC, kidney, skin, melanoma, gastric, pancreatic, HCC, rectal, sarcoma, head and neck, esophagus, biliary tract

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Last line

Investigational Agent

nab-sirolimus

Drug Class

MTOR inhibitor

PI

Dan Vaena, MD

Sponsor

Aadi Bioscience, Inc.

Path

TSC1 or TSC2 alterations

Key Eligibility Criteria Details

Malignant solid tumor with pathogenic inactivating TSC1 or TSC2 alterations. GEnetic alterations should be identified using NGS in tumor tissue or liquid biopsy
Metastatic or locally advanced solid tumors
Must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the investigator, the patient would b e unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy
Measurable disease
ECOG PS 0-1
Fasting tryglecerid must be < or = 300; fast serus cholesterol must be < or = to 350
No prior treatment with MTOR inhibitor
No primary brain tumors
No known HIV

ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
Must have tumor specimen available
Measurable disease
ECOG PS 0-1
Life expectancy at least 12 weeks
Phase 1a- must have exhausted all standard therapies for their disease
Phase 1b- must have disease that has progressed after at least one available standard therapy
Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
No active HBV/HCV or chronic or acute EBV
No history of autoimmune disease
No symptomatic or actively progressing CNS mets

ADVANCED SOLID TUMORS: PHASE 1: NKG2A inhibitor: CA047004

A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination with Nivolumab or
Cetuximab in Participants with Advanced Solid Tumors

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Malignancy

Advanced Solid Tumors, renal cell, head and neck cancer (SCCHN), non-small cell lung cancer (NSCLC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

> or = 2nd line

Investigational Agent

BMS-986315 with either nivolumab or cetuximab

Drug Class

NKG2A inhibitor

PI

Dan Vaena, MD

Sponsor

Bristol-Myers Squibb

Path

Key Eligibility Criteria Details

Renal cell, NSCLC, or SCCHN
Must have received prior PD-1 or PD-L1 inhibitor
ECOG PS 0-1
No known autoimmune disease
No need for steroids or other immunsuppressive medicine
No interstitual lung disease or pulmonary fibrosis