PHASE 1/1B, MULTICENTER, OPEN-LABEL, STUDY OF RMC-9805 IN PARTICIPANTS WITH ADVANCED KRASG12D-MUTANT SOLID TUMORS

ENROLLING
Protocol # :
23-571
Conditions
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Advanced Solid Tumors
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
Parikh, Aparna, Raj
Site Research Nurses
Aspinwall, Sheridan
Callahan, Carragh
Carr, Margaret, M.
Channell, Kelly
Connelly, Alexandra
Conway, Ellen
Dailey, Erin
Giannandrea, Gianna
Graham, Christopher
Hurley, Meaghan
Janell, Samantha
Jellison, Shawna
Kelley, Elaine
Lam, Ethan
Ly, Christina
McHugh, Kimberly
McIntyre, Casandra
Mcnally, Megan
Platia, Delaney
Ritterband, Lauren
Rivenburgh, Rebecca, Elizabeth
Sawin, Mark
Souza, Joseph
Spriggs, Kristen
Sullivan, Molly, O'Brien
Sutcliffe, Shaun
Vanasse, Katherine

Trial Description

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in
combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Eligibility Requirements

Inclusion Criteria:

- Pathologically documented, locally advanced or metastatic solid tumor with a KRAS
G12D-mutation

- Received and progressed or been intolerant to prior standard therapy (including
targeted therapy) appropriate for tumor type and stage

- ECOG performance status 0 or 1

- Adequate organ function

Exclusion Criteria:

- Primary central nervous system (CNS) tumors

- Known or suspected leptomeningeal or active brain metastases or spinal cord
compression

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

- Participant was previously treated with an investigational KRAS G12D inhibitor, pan-
or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy
(eg, degraders and inhibitors)

Other inclusion/exclusion criteria may apply.

23-571