NCT03634982

Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants With Relapsed/Refractory Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Revolution Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	RMC-4630	RMC-4630 for oral administration

Timeline

• Start date: 2018-09-28
• Primary completion: 2023-03-31
• Completion: 2023-05-31
• First posted: 2018-08-17
• Last updated: 2022-09-01

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study