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RAS Inhibitor

RMC-6236 for Pancreatic Cancer (RASolute 302 Trial)

Phase 3

Recruiting

Research Sponsored by Revolution Medicines, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed PDAC with metastatic disease

Documented RAS mutation status, either mutant or wild-type. Eligible RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)

Must not have

Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors)

Patient is unable or unwilling to comply with protocol-required study visits or procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to test a new drug to see if it is safe and effective in treating a certain condition, comparing it to the current standard treatments."

Who is the study for?

This trial is for patients with advanced pancreatic cancer (PDAC) who have already undergone treatment. Participants should be adults with a confirmed diagnosis and measurable disease, able to perform daily activities with relative independence.

What is being tested?

The study tests RMC-6236, a new potential drug targeting specific cancer pathways, against standard chemotherapy treatments like 5-fluorouracil, irinotecan, nab-paclitaxel, gemcitabine, oxaliplatin and liposomal irinotecan combined with leucovorin.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues such as nausea, vomiting, diarrhea or constipation; fatigue; hair loss; lowered blood cell counts leading to increased infection risk; and possible liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer has spread and was confirmed by lab tests.

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My cancer has a known RAS mutation status.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs targeting RAS proteins.

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I cannot or do not want to follow the study's required visits or procedures.

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I have or had cancer spread to my brain or spinal cord.

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I have not had major surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS) in the RAS G12-mutant population

Progression free survival (PFS) in the RAS G12-mutant population

Secondary study objectives

Duration of response (DOR) in RAS G12 and all-patient populations

OS in the all-patient population

Objective response in the RAS G12 and all-patient populations

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RMC-6236Experimental Treatment1 Intervention

Study drug

Group II: Investigator's choice of standard of care therapyActive Control7 Interventions

Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments: * Gemcitabine and nab-paclitaxel (GnP) * Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX) * Liposomal irinotecan (Nal-IRI + 5-FU/LV) * Oxaliplatin, leucovorin and 5-FU IV (FOLFOX)

0 / 7Eligibility criteria met