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
RasCal Therapeutics, Inc.
134 participants
Mar 3, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Participant is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
- Malignancy has progressed on standard therapy
- Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
- Is age ≥ 18 years.
- Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS
Exclusion Criteria7
- Participants receiving cancer therapy at the time of enrollment.
- Any clinically significant disease or condition affecting a major organ system.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
- Known Gilbert's disease.
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer.
- Intermittent hypokalemia
- Grade 1 or higher nausea, vomiting, diarrhea at baseline due to underlying disease
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04678648