A Multicenter Open-Label Study of RMC-6236 in Patients with Advanced Solid Tumors Harboring Specific Mutations in RAS

ENROLLING
Protocol # :
22-297
Conditions
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Advanced Solid Tumors
Phase
I/II
Disease Sites
Healthy volunteer
Transplanted organ and tissue status, unspecified
Disease not specified
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
Mycosis Fungoides
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
Donors
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Wolpin, Brian, M
Site Research Nurses
Aspinwall, Sheridan
Barber, Leslie
Barber, Leslie
Becker, Simone
Belavusava, Vera
Bravo, Caitlin
Bretta, Katherine
Callahan, Carragh
Connelly, Alexandra
Dailey, Erin
Eggenberger, Brooke
Engelbrecht, Liliana
Gillen McKay, Christine, A.
Graham, Christopher
Hindenach, Sarah, E.
Janell, Samantha
Jellison, Shawna
Kelley, Elaine
Kleeman, Allison, M.
Lam, Ethan
Lawson, Susan
Libertini, Kelsie, Elizabeth
McNally, Megan
Morrissey, Stephanie, C.
Neals, Allison
Platia, Delaney
Ritterband, Lauren
Santorelli, Jill, Kathleen
Sawin, Mark

Trial Description

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant
advanced solid tumors.

Eligibility Requirements

Inclusion Criteria:

- Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose
escalation) or RAS mutations (dose optimization/expansion) identified through
deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).

- Treatment naive or have received prior standard therapy appropriate for tumor type
and stage

- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate organ function

Exclusion Criteria:

- Primary central nervous system (CNS) tumors

- Active, untreated brain metastases

- Known or suspected impairment of gastrointestinal function that may prohibit ability
to swallow or absorb an oral medication

- History of any other unstable or clinically significant concurrent medical condition
that would, in the opinion of the investigator, jeopardize the safety of a
participant, impact their expected survival through the end of the study
participation, and/or impact their ability to comply with the protocol
prior/concomitant therapy

Other inclusion/exclusion criteria may apply.

22-297