Actively Recruiting
A Phase 1a/1b Open-Label Study of Oral RSC-1255 Alone or With Hydroxychloroquine for Advanced Solid Tumor Cancers
Led by RasCal Therapeutics, Inc. · Updated on 2026-03-18
134
Participants Needed
3
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating RSC-1255, a small-molecule oral drug that targets mutant and wild-type RAS proteins, in adults with advanced solid tumor cancers who have not responded to standard treatments or cannot tolerate them. This Phase 1a/1b study aims to find the right dose of RSC-1255 and then assess its safety and effectiveness in treating these difficult cancers. The trial involves participants with tumors that have RAS mutations or glioblastoma, regardless of mutation status. Participants receive RSC-1255 orally twice daily throughout the study. The trial has two phases: Phase 1a (Dose Escalation) enrolls 40 to 80 participants to determine the maximum tolerated dose and recommended dose over 21-day treatment cycles. Phase 1b (Dose Expansion) includes 48 to 94 participants who receive RSC-1255 alone or combined with hydroxychloroquine, an autophagy inhibitor, to further study safety, drug behavior, and clinical outcomes. During the study, participants undergo regular tumor assessments using scans and laboratory tests to measure response and disease progression. Researchers monitor safety by recording side effects and adverse events. The primary outcomes include identifying the maximum tolerated dose and recommended dose for future studies. Secondary outcomes involve overall survival and disease progression over approximately two years. Participation duration varies depending on treatment response and study phase.
CONDITIONS
Brief Title
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed advanced or metastatic malignancy
- Intolerant to or progressed after existing therapies known to provide clinical benefit
- Measurable or evaluable tumor(s) by standard assessments
- Adequate performance status (ECOG)
- Tumors with documented RAS mutations or glioblastoma with or without RAS mutation
You will not qualify if you...
- Receiving other cancer therapy at enrollment
- Significant disease affecting major organs
- Significant cardiovascular disease or abnormal ECG
- Known Gilbert's disease
- Previous or current malignancy other than the target cancer within 2 years
- Intermittent low potassium levels (hypokalemia)
- Baseline nausea, vomiting, or diarrhea of grade 1 or higher due to underlying disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 30 months
Participants receive oral RSC-1255 twice daily, alone or in combination with hydroxychloroquine, in repeated 21-day cycles.
Trial Site Locations
Total: 3 locations
1
University of California, Los Angeles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90404
Actively Recruiting
2
Sarah Cannon, SCRI Oncology Partners - Health One
Denver, Colorado, United States, 80218
Actively Recruiting
3
Sarah Cannon, SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
B
Bonnie Wettersten, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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