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

MC #22-17

NCT #
Condition(s)
Colorectal Cancer, Lung Cancer (NSCLC), Pancreatic Cancer, Solid Tumor
Molecular Target(s)
KRAS G12, KRAS G12C, KRAS G12D, KRAS MUTATION
Drug Classification(s)
Molecular Targeted Therapy
Agents(s)
RMC-6236
Phase(s)
I

Mechanism of Action

RMC-6236 inhibits the RAS(ON) state of multiple RAS variants both mutant and wild-type proteins.

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of the study drug can be given with an acceptable level of side effects
  • The effects of the study drug (good and bad)
  • How much of the study drug is absorbed into the blood and how fast it is removed
  • If research tests can be used in the future to predict who will benefit from RMC-6236

Study Design

This is a dose escalation/expansion study, which means the study is divided into two parts. In the dose escalation part of the study (Part 1), the amount of the study drug given will be increased in each group of research participants, to find the most appropriate dose for further study.  In the dose expansion/dose optimization part of the study (Part 2), a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study.  The dose of the study drug you receive will be determined by when you enroll into the study and what part of the study you take part in.

The study treatment will be given in cycles.  Each cycle is 21 days. You will receive the study drug as tablets by mouth, once daily and will take it with 8 ounces of water. On the days that you take the study drug, you should not eat or drink for 2 hours before and 1 hour after taking the study drug, unless otherwise instructed by study staff. This excludes water, which is allowed at any time during this fasting interval.

Location

Mary Crowley Cancer Research - Medical City Dallas

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