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

Part of paid clinical trials in Orange, California.

Sponsor
Revolution Medicines, Inc.
Study ID
NCT05379985
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Advanced Solid Tumors
  • Colorectal Cancer (CRC)
  • Non-small Cell Lung Cancer (NSCLC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RMC-6236 — DRUG
    Oral Tablets

Study Details

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

Key Dates

Start date
May 31, 2022
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Jul 26, 2027

Study Design

Enrollment
754 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: RMC-6236
    Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations. Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NSCLC, PDAC, CRC, RAS mutant NSCLC, Melanoma, gynecological cancer or other solid tumors not previously specified). RAS mutant is defined as any nonsynonymous mutation of KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)

Primary Outcome Measure

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 ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
UC Irvine/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UCLASanta MonicaCalifornia90404-
Moffitt Cancer CenterTampaFlorida33612-
Piedmont HealthcareAtlantaGeorgia30318-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
Johns Hopkins UniversityBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Columbia UniversityNew YorkNew York10032-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-
Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Christ Hospital Cancer CenterCincinnatiOhio45219-
Taylor Cancer Research CenterMaumeeOhio43537-
Tennessee OncologyChattanoogaTennessee37404-
Sarah Cannon Research InstituteNashvilleTennessee37203-
University of Texas at AustinAustinTexas78712-
Mary Crowley Cancer ResearchDallasTexas75230-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Next OncologySan AntonioTexas78229-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Next Oncology VirginiaFairfaxVirginia22031-
Virginia Mason Medical CenterSeattleWashington98101-

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