Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.
This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose \[RP2D\] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
754
Oral Tablets
UC Irvine/Chao Family Comprehensive Cancer Center
Orange, California, United States
RECRUITINGUCLA
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
Number of Participants with Dose-Limiting Toxicity (DLT)
Time frame: 21 days
Maximum Observed Blood Concentration (Cmax) of RMC-6236
Time frame: up to 15 weeks
Time to Reach Maximum Blood Concentration (Tmax) of RMC-6236
Time frame: up to 15 weeks
Area Under Blood Concentration Time Curve (AUC) of RMC-6236
Time frame: up to 15 weeks
Elimination Half-Life of RMC-6236 (t1/2)
Time frame: up to 15 weeks
Ratio of accumulation of RMC-6236 from a single dose to steady state with repeated dosing
Time frame: up to 15 weeks
Overall Response Rate (ORR)
Overall response rate per RECIST v1.1
Time frame: up to 2.5 years
Duration of Response (DOR)
Duration of response per RECIST v1.1
Time frame: up to 2.5 years
Disease Control Rate (DCR)
Disease control rate per RECIST v1.1
Time frame: up to 2.5 years
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Santa Monica, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGPerlmutter Cancer Center at NYU Langone Health
New York, New York, United States
RECRUITINGMemorial Sloan-Kettering Cancer Center
New York, New York, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITINGChrist Hospital Cancer Center
Cincinnati, Ohio, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
RECRUITING...and 6 more locations
Time to Response (TTR)
Time to response per RECIST v1.1
Time frame: up to 2.5 years
Progression-Free Survival (PFS)
Progression-free survival per RECIST v1.1
Time frame: up to 2.5 years