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RECRUITING
NCT04678648
PHASE1

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

Sponsor: RasCal Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2021-03-03

Completion Date

2027-01-30

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

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.

Locations (3)

University of California, Los Angeles (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