A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies

Status Recruiting

Clinical Trial Summary

RSC-101 is a Phase 1a/1b clinical trial of RSC-1255 in adult study participants with advanced solid tumor malignancies who are intolerant of existing therapies known to provide clinical benefit, have disease that has progressed after standard therapy, or have previously failed other therapies. The study has two phases. The purpose of Phase 1a (Dose Escalation) is to confirm the appropriate treatment dose and Phase 1b (Dose Expansion) is to characterize the safety and efficacy of RSC-1255.

Clinical Trial Description

RSC-1255 is an orally bioavailable, small-molecule direct pan-mutant and wild-type RAS inhibitor. RSC-101 is a Phase 1a/1b, open-label, multi-center, non-randomized, Dose Escalation and Dose Expansion study in participants with advanced solid tumor malignancies. Study enrollment is approximately 134 participants. All participants receive oral RSC-1255, twice daily as monotherapy. Following Phase 1a (Dose Escalation) to identify the Maximum Tolerated Dose and Recommended Dose for use in Phase 1b, additional participants are enrolled in the Phase 1b (Dose Expansion) to further characterize the safety, pharmacology, and the clinical efficacy of RSC-1255. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04678648
Study type	Interventional
Source	RasCal Therapeutics, Inc.
Contact	Bonnie Wettersten, MS
Phone	(847) 644-9818
Email	clinicaltrials@rascaltherapeutics.com
Status	Recruiting
Phase	Phase 1
Start date	February 16, 2021
Completion date	March 5, 2024

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