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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06445062
Other study ID # RMC-GI-102
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 24, 2024
Est. completion date July 15, 2027

Study information

Verified date May 2024
Source Revolution Medicines, Inc.
Contact Revolution Medicines
Phone 650-779-2300
Email CT-inquiries@RevMed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 first three 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


Description:

The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on GI cancers. This is an open-label platform study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC) or with novel agents, and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with RAS mutations will be specified in each subprotocol. Subprotocol A is an open-label, multicenter study of RMC-6236 in combination with 5-fluorouracil-based regimens in patients with unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol B is an open-label, multicenter study of RMC-6236 in combination with cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol C is an open-label, multicenter study of RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.


Recruitment information / eligibility

Status Recruiting
Enrollment 406
Est. completion date July 15, 2027
Est. primary completion date May 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - Must have pathologically documented, pancreatic carcinoma with documented metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A and B) - Must have pathologically documented, poorly differentiated pancreatic carcinoma with documented metastatic disease (Subprotocol C) - 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.

Study Design


Intervention

Drug:
RMC-6236
Oral tablet
mFOLFOX6 regimen
IV infusion
bevacizumab
IV infusion
mFOLFIRINOX regimen
IV infusion
cetuximab
IV infusion
gemcitabine
IV infusion
nab-paclitaxel
IV infusion

Locations

Country Name City State
United States Virginia Cancer Specialists Fairfax Virginia
United States NEXT Oncology Dallas Irving Texas

Sponsors (1)

Lead Sponsor Collaborator
Revolution Medicines, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Evaluate the safety and tolerability in the study population characterized by incidence, abnormal laboratory assessments, severity, and seriousness of adverse events in relation to the study treatment. Up to 3 years
Primary Dose limiting toxicities Number of participants with dose limiting toxicities 28 days
Secondary Pharmacokinetics of RMC-6236 Blood concentration of RMC-6236 over time 21 weeks
Secondary ORR Overall Response Rate per RECIST v1.1 Up to 3 years
Secondary DOR Duration of Response per RECIST v1.1 Up to 3 years
Secondary DCR Incidence of Response per RECIST v1.1 Up to 3 years
Secondary TTR Time to Response per RECIST v1.1 Up to 3 years
Secondary PFS Progression Free Survival per RECIST v1.1 Up to 3 years
Secondary OS Overall Survival Up to 3 years
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