A Platform Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors

ENROLLING
Protocol # :
24-325
Conditions
Colorectal Cancer
CRC
Pancreatic Ductal Adenocarcinoma
PDAC
Gastrointestinal Cancer
Metastatic Pancreatic Ductal Adenocarcinoma
Phase
I/II
Disease Sites
Colon
Rectum
Pancreas
Principal Investigator
Wolpin, Brian, M
Site Research Nurses
Connelly, Alexandra
Giannandrea, Gianna
Graham, Christopher
Lawson, Susan
Ritterband, Lauren
Sawin, Mark
Vanasse, Katherine

Trial Description

The purpose of this platform study is to evaluate the safety, tolerability,
pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors
combined with Standard(s) of Care (SOC) or with novel agents.

The current subprotocols include the following:

Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens

Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6

Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel

Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens

Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6

Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel

Eligibility Requirements

Inclusion Criteria:

All Patients (unless otherwise noted):

- ≥ 18 years of age

- ECOG PS is 0 to 1

- Adequate organ function as outlined by the study

- Pathologically or cytologically documented pancreatic carcinoma or poorly
differentiated pancreatic carcinoma with metastatic disease or RAS-mutated,
histologically or cytologically confirmed colorectal adenocarcinoma with documented
unresectable or metastatic disease (Subprotocol A, B, and C)

- Presence of RAS G12D mutation (Subprotocol D, E, F)

Exclusion Criteria:

All Patients:

- Primary central nervous system (CNS) tumors

- Impaired gastrointestinal (GI) function that may significantly alter the absorption
of RMC drugs

- Major surgery within 28 days of first dose

Other inclusion/exclusion criteria may apply.

24-325