Advanced KRASG12C Mutant Solid Tumors KRASG12C NSCLC Advanced KRASG12C Mutant Solid Tumors KRASG12C NSCLC with or without prior exposure to KRASG12C(OFF) inhibitor
Conditions
Interventions
RMC-6291-001, Oral tablet once or twice a day
Sponsors
Revolution Medicines, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subject must be equal or more than 18 years of age. 2. Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments. 3. ECOG performance status 0 or 1 4. Prior treatment with a KRASG12C (OFF) inhibitor allowed 5. Adequate organ function
Exclusion criteria
Exclusion criteria: 1. Primary central nervous system (CNS) tumors 2. Active brain metastases 3. Known impairment of GI function that would alter the absorption 4. Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment. 5. Prior therapy with KRASG12C (ON) inhibitor 6. Other inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events [ Time Frame: up to 3 years ] 3 years Number of participants with adverse events,Dose Limiting Toxicities [ Time Frame: The first 21 days (i.e. Cycle 1) ] 21 days Number of participants with dose limiting toxicities | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Blood Concentration of RMC-6291 [ Time Frame: 7 Cycles] 7 Cycles Cmax,Time to Reach Maximum Blood Concentration of RMC-6291 [ Time Frame: 7 Cycles] 7 Cycles Tmax,Area Under Blood Concentration Time Curve of RMC-6291 [ Time Frame: 7 Cycles ] 7 Cycles AUC,Elimination Half-Life of RMC-6291 [ Time Frame: 7 Cycles] 7 Cycles t1/2,Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing [ Time Frame: 7 Cycles ] 7 Cycles accumulation ratio,Overall Response Rate (ORR) [ Time Frame: 3 years ] 3 years Overall response rate per RECIST v1.1,Duration of Response (DOR) [ Time Frame: 3 years ] 3 Years Duration of response per RECIST v1.1,Disease Control Rate (DCR) [ Time Frame: 3 years ] 3 years Disease control rate per RECIST v1.1,Time to Response (TTR) [ Time Frame: 3 years ] 3 years Time to response per RECIST v1.1,Progression-Free Survival (PFS) [ Time Frame: 3 years ] 3 years Progression-free survival per RECIST v1.1 | — |
Countries
Thailand
Contacts
Public ContactRevolution Medicines Inc
Revolution Medicines, Inc.
Outcome results
None listed