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

NCT04678648 · RasCal Therapeutics, Inc.
In plain English

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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
About this study
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).
Eligibility criteria
Inclusion Criteria (Key Factors): 1. 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 2. Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy. 3. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG). 4. Is age ≥ 18 years. 5. Has either tissue agnostic tumors and documented RAS mutations or with glioblastoma with or without mutation in RAS Exclusion Criteria (Key Factors): 1. Participants receiving cancer therapy at the time of enrollment. 2. Any clinically significant disease or condition affecting a major organ system. 3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities. 4. Known Gilbert's disease. 5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer. 6. Intermittent hypokalemia 7. Grade 1 or higher nausea, vomiting, diarrhea at baseline due to underlying disease
Study design
Enrollment target: 134 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-03-03
Estimated completion: 2027-01-30
Last updated: 2026-03-18
Interventions
Drug: RSC-1255 Dose EscalationDrug: RSC-1255 Dose Expansion
Primary outcomes
  • Maximum Tolerated Dose (MTD) for RSC-1255 as monotherapy (Approximately 30 months)
  • Recommended Phase 2 Dose (RP2D) for RSC-1255 as monotherapy (Approximately 12 months)
Sponsor
RasCal Therapeutics, Inc. · industry
Contacts & investigators
ContactBonnie Wettersten, MS · contact · clinicaltrials@rascaltherapeutics.com · (847) 644-9818
InvestigatorMichael Mann, MD · study_director, RasCal Therapeutics, Inc.
All locations (3)
University of California, Los Angeles (UCLA) Department of Medicine - Hematology/OncologyRecruiting
Los Angeles, California, United States
Sarah Cannon, SCRI Oncology Partners - Health OneRecruiting
Denver, Colorado, United States
Sarah Cannon, SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies · TrialPath