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

Phase 1

Recruiting

• Conditions: RAS Mutation; Lung Cancer; Glioblastoma; Pancreatic Cancer; Advanced Malignant Solid Neoplasm; Colon Cancer
• Interventions: Drug: RSC-1255 Dose Escalation; Drug: RSC-1255 Dose Expansion

• Registration Number: NCT04678648
• Lead Sponsor: RasCal Therapeutics, Inc.

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-22
• Study Start: 2021-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-12-15
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RSC-1255 Treatment	RSC-1255 Dose Escalation	Single Arm Study. All study participants receive RSC-1255.
RSC-1255 Treatment	RSC-1255 Dose Expansion	Single Arm Study. All study participants receive RSC-1255.

Primary Outcome Measures

Name	Time	Method
Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy	Approximately 12 months	The number and type of DLTs as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all treatment-related adverse events using CTCAE 5.0 will be used to identify a safe and tolerable dose.
Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy	Approximately 30 months	The number and type of dose-limiting toxicities (DLTs) as defined in the protocol that occur during the first 28 days of treatment and all maximum grade of all maximum grade of all treatment-related events using CTCAE V5.0 will be used to identify a safe and tolerable dose.

Secondary Outcome Measures

Name	Time	Method
Adverse event profile of RSC-1255	Approximately 24 months	Toxicities will be graded according to CTCAE V5.0.
Overall Survival (OS)	Approximately 24 months	Overall Survival will be assessed using RECIST V1.1.

Trial Locations

Locations (3)

University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

Sarah Cannon, SCRI Oncology Partners - Health One; 🇺🇸 Denver, Colorado, United States

Sarah Cannon, SCRI Oncology Partners; 🇺🇸 Nashville, Tennessee, United States