Ph Ib RMC-6291 in Comb w/ RMC-6236 in Pts w/ Adv KRASG12C Mutated Solid Tumors

UCI Specialty Area: Cancer

Principal Investigator: Sai-Hong Ou

Official Title: Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C-Mutated Solid Tumors

A Study On:

Anus

Bones and Joints

Brain and Nervous System

Breast

Cervix

Colon

Corpus Uteri

Esophagus

Eye and Orbit

Ill-Defined Sites

Kaposis sarcoma

Kidney

Larynx

Lip Oral Cavity and Pharynx

Liver

Lung

Melanoma skin

Other Digestive Organ

Other Endocrine System

Other Female Genital

Other Male Genital

Other Respiratory and Intrathoracic Organs

Other Skin

Other Urinary

Ovary

Pancreas

Prostate

Rectum

Small Intestine

Soft Tissue

Stomach

Thyroid

Unknown Sites

Urinary Bladder

Study Description

This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

Eligibility

18 years of age

Histology: pathologically, KRAS G12C-mutated, documented advanced or metastatic solid tumors not amendable to curative therapy

Part 1. Dose Escalation: solid tumors, previously treated

Part 2. Dose Expansion:

i.Non-small cell lung cancer (NSCLC), previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors,

ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve to KRAS G12C (OFF) inhibitors,

iii. NSCLC, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases <2 cm in size

iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.

ECOG performance status 0 or 1

Adequate organ function

i. Primary central nervous system (CNS) tumors

ii. Active brain metastases

iii. Known impairment of gastrointestinal function that would alter the absorption

iv. Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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