A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
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- STATUS
- Recruiting
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- End date
- Mar 5, 2024
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- participants needed
- 134
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- 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.
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.
Details
| Condition | Advanced Malignant Solid Neoplasm, RAS Mutation, Lung Cancer, Colon Cancer, Glioblastoma, Pancreatic Cancer |
|---|---|
| Treatment | RSC-1255 Dose Escalation, RSC-1255 Dose Expansion |
| Clinical Study Identifier | NCT04678648 |
| Sponsor | RasCal Therapeutics, Inc. |
| Last Modified on | 22 March 2022 |
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