NCT04678648

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

A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 Alone or in Combination With Hydroxychloroquine in Patients With Advanced Solid Tumor Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: RasCal Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 as monotherapy and in combination with the autophagy inhibitor hydroxychloroquine (HCQ).

Conditions

• Advanced Malignant Solid Neoplasm
• RAS Mutation
• Lung Cancer
• Colon Cancer
• Glioblastoma
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	RSC-1255 Dose Escalation	Phase 1a will enroll 40-80 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, with and without food. Each cycle is 21 days.
DRUG	RSC-1255 Dose Expansion	Phase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days.

Timeline

• Start date: 2021-03-03
• Primary completion: 2026-12-15
• Completion: 2027-01-30
• First posted: 2020-12-22
• Last updated: 2026-03-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study