Phase 1a1b Study of RSC-1255 Alone or With Hydroxychloroquine for Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating RSC-1255, an oral small-molecule inhibitor targeting pan-mutant and wild-type RAS, in adults with advanced solid tumor cancers who have not responded to or cannot tolerate existing therapies. This open-label Phase 1a1b study aims first to find the correct dose and then to assess the safety and efficacy of RSC-1255 alone or combined with hydroxychloroquine. Approximately 134 participants with various advanced cancers, including lung, colon, glioblastoma, pancreatic cancer, and others with RAS mutations, are expected to enroll. Participants receive oral RSC-1255 twice daily in all study phases. Phase 1a Dose Escalation involves 40-80 participants to determine toxicity limits and the recommended dose, with treatment cycles lasting 21 days. Phase 1b Dose Expansion enrolls 48-94 participants to further evaluate safety, pharmacology, and clinical effects of RSC-1255, given alone or with hydroxychloroquine, also in 21-day cycles. Treatment is continuous, taken with or without food depending on the phase. Throughout the study, participants undergo tumor assessments using imaging and laboratory tests. Researchers monitor overall survival, disease progression, adverse events, and safety during approximately 24-30 months of follow-up. The study tracks maximum tolerated dose and recommended dose over time, with careful evaluation of treatment effects and tolerability. Participants are observed closely during treatment cycles to evaluate responses and side effects until study completion around 2027.

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