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A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
Sponsor: RasCal Therapeutics, Inc.
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
Conditions
Interventions
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.
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