The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).
This is an open-label, multicenter, Phase 1 study of oral RMC-4630 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the RAS-MAPK pathway. Participants 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
133
RMC-4630 for oral administration
Honor Health Research Institute
Scottsdale, Arizona, United States
City of Hope
Duarte, California, United States
UC Irvine - Chao Family Comprehensive Cancer Center
Orange, California, United States
Number of participants with adverse events (AEs)
Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values and vital signs for RMC-4630 monotherapy
Time frame: up to 3 years
Number of participants with dose limiting toxicities (DLTs)
Incidence and nature of DLTs with RMC-4630 monotherapy
Time frame: 28 days
Cmax
Peak plasma concentration of RMC-4630
Time frame: up to 3 years
Tmax
Time to achieve peak plasma concentration of RMC-4630
Time frame: up to 3 years
Area Under the Curve (AUC)
Area under the plasma concentration time curve of RMC-4630
Time frame: up to 3 years
t1/2
Elimination half-life of RMC-4630
Time frame: up to 3 years
Accumulation Ratio
Ratio of accumulation of RMC-4630 from a single dose to steady state with repeated dosing
Time frame: up to 3 years
Overall Response Rate (ORR)
Overall response rate of RMC-4630 per RECIST v1.1
Time frame: up to 3 years
Duration of Response (DOR)
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UC Davis Comprehensive Cancer Center
Sacramento, California, United States
UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Sarah Cannon Research Institute - Florida Cancer Specialists
Sarasota, Florida, United States
Moffit Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
...and 2 more locations
Duration of response of RMC-4630 per RECIST v1.1
Time frame: up to 3 years