Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C-Mutated Solid Tumors

NOT ENROLLING
Protocol # :
23-609
Conditions
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Phase
I
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Other specified personal risk factors, not elsewhere classified
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Janne, Pasi, A
Site Research Nurses
Aspinwall, Sheridan
Becker, Simone
Callahan, Carragh
Connelly, Alexandra
Dailey, Erin
Giannandrea, Gianna
Graham, Christopher
Hurley, Meaghan
Janell, Samantha
Jellison, Shawna
Kelley, Elaine
Lam, Ethan
McHugh, Kimberly
Mcnally, Megan
Platia, Delaney
Ritterband, Lauren
Sawin, Mark
Souza, Joseph
Sullivan, Molly, O'Brien

Trial 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 Requirements

Inclusion Criteria:

- 18 years of age

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

1. Part 1. Dose Escalation: solid tumors, previously treated

2. Part 2. Dose Expansion:

i. 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

Exclusion Criteria:

- Primary central nervous system (CNS) tumors

- Active brain metastases

- Known impairment of GI function that would alter the absorption

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

23-609