Status and phase
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About
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.
Full 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.
Enrollment
Sex
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Inclusion and exclusion criteria
Inclusion Criteria (Key Factors):
Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
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.
Exclusion Criteria (Key Factors):
Primary purpose
Allocation
Interventional model
Masking
134 participants in 1 patient group
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Central trial contact
Bonnie Wettersten, MS
Data sourced from clinicaltrials.gov
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