The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
222
Oral tablet once or twice a day
Highlands Oncology Group
Springdale, Arkansas, United States
UC Irvine Cancer Center
Orange, California, United States
UC Davis Cancer Center
Sacramento, California, United States
UCSF
San Francisco, California, United States
University of Miami School of Medicine Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Adverse events
Number of participants with adverse events
Time frame: up to 3 years
Dose Limiting Toxicities
Number of participants with dose limiting toxicities
Time frame: The first 21 days (i.e. Cycle 1)
Maximum Observed Blood Concentration of RMC-6291
Cmax
Time frame: 7 Cycles
Time to Reach Maximum Blood Concentration of RMC-6291
Tmax
Time frame: 7 Cycles
Area Under Blood Concentration Time Curve of RMC-6291
AUC
Time frame: 7 Cycles
Elimination Half-Life of RMC-6291
t1/2
Time frame: 7 Cycles
Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing
accumulation ratio
Time frame: 7 Cycles
Overall Response Rate (ORR)
Overall response rate per RECIST v1.1
Time frame: 3 years
Duration of Response (DOR)
Duration of response per RECIST v1.1
Time frame: 3 years
Disease Control Rate (DCR)
Disease control rate per RECIST v1.1
Time frame: 3 years
Time to Response (TTR)
Time to response per RECIST v1.1
Time frame: 3 years
Progression-Free Survival (PFS)
Progression-free survival per RECIST v1.1
Time frame: 3 years
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Moffitt Cancer Center
Tampa, Florida, United States
American Oncology Partners of Maryland
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
MSK Cancer Center
New York, New York, United States
...and 54 more locations