Open-label, Non-randomized, Multi-cohort Phase 1b/2 Trial of STC-15 With Toripalimab in Selected Advanced Cancers and as Monotherapy in Selected Sarcomas

What this Trial Is About

Researchers are investigating the safety, tolerability, and antitumor activity of STC-15, a METTL3 inhibitor, combined with toripalimab, an anti-PD-1 therapy, in people with advanced, unresectable, or metastatic tumors. This early phase oncology trial also includes a Phase 2 study focusing on STC-15 as a single treatment in patients with specific relapsed sarcoma subtypes, including dedifferentiated liposarcoma and leiomyosarcoma. The study uses an open-label, non-randomized design to assess these treatments in select cancer types. The trial includes multiple study groups: a Phase 1b dose escalation phase where participants receive STC-15 combined with toripalimab in 21-day cycles, and Phase 2 monotherapy cohorts where participants with certain sarcomas receive STC-15 alone in similar 21-day cycles. The Phase 2 part follows a Simon's 2-stage design to evaluate the monotherapy's safety and antitumor effects. Treatments are given under close monitoring at various study centers. Participants will undergo assessments including tumor measurements based on RECIST v1.1 criteria, safety and tolerability evaluations, and collection of plasma samples to measure drug concentration over time. Biopsies may be performed if medically feasible. The main outcomes measured are safety and antitumor activity over six months, with additional pharmacokinetic assessments within 22 days. The total study duration includes follow-up to monitor treatment effects and participant well-being.

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas