Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

About this trial

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).

Treatment naive or have received prior standard therapy appropriate for tumor type and stage

Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequate organ function

Disqualifiers

Primary central nervous system (CNS) tumors

Active, untreated brain metastases

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

History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • RMC-6236

    Drug

    Oral Tablets

Treatment groups

754 Participants
are divided into 1 treatment group
Group A: Experimental: RMC-6236Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs

Time frame
up to 2.5 years
2

Number of Participants with Dose-Limiting Toxicity (DLT)

Time frame
21 days

Secondary outcomes

1

Maximum Observed Blood Concentration (Cmax) of RMC-6236

Time frame
up to 15 weeks
2

Time to Reach Maximum Blood Concentration (Tmax) of RMC-6236

Time frame
up to 15 weeks
3

Area Under Blood Concentration Time Curve (AUC) of RMC-6236

Time frame
up to 15 weeks
4

Elimination Half-Life of RMC-6236 (t1/2)

Time frame
up to 15 weeks

Other outcomes

Sponsors and contacts

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