Study of STC-15 with Toripalimab for Advanced Cancers and STC-15 Alone for Certain Sarcomas

What this Trial Is About

Researchers are evaluating the safety, tolerability, and antitumor activity of STC-15, a METTL3 inhibitor, both alone and in combination with toripalimab, an anti-PD-1 therapy, in people with advanced unresectable or metastatic tumors. This early phase oncology trial includes a Phase 1b dose escalation study and a Phase 2 monotherapy part focusing on selected relapsed sarcoma subtypes such as dedifferentiated liposarcoma and leiomyosarcoma. The study aims to understand how these treatments perform in these difficult-to-treat cancers. Participants in the Phase 1b part receive STC-15 combined with toripalimab in 21-day treatment cycles, focusing on dose escalation to determine safety and tolerability. In the Phase 2 monotherapy part, participants with specific sarcoma subtypes receive STC-15 alone in 21-day cycles. Both parts are open-label and non-randomized, conducted at multiple centers. The trial evaluates both combination therapy and monotherapy separately to understand their effects. During the study, participants undergo regular assessments including imaging to measure tumor response, laboratory tests to monitor drug levels and organ function, and safety evaluations. The primary outcomes include safety and tolerability over 6 months, and antitumor activity for both combination and monotherapy cohorts. Participants are followed for up to 6 months to assess treatment effects and side effects. The trial is led by STORM Therapeutics LTD and aims to provide important information about these experimental therapies.

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