A Phase 1 interventional study of RMC-4630 in Solid Tumors, sponsored by Revolution Medicines, Inc.. Status unknown at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by Revolution Medicines, Inc. · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 133 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Revolution Medicines, Inc. is the lead sponsor of 19 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RMC-4630 for oral administration
Drug: RMC-4630
RMC-4630 for oral administration
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)
Duration of response of RMC-4630 per RECIST v1.1
Time frame: up to 3 years
Plan to share: No
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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Revolution Medicines, Inc.