Clinical Trial

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

Recruiting Phase 1/2
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Summary
This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in advanced unresectable or metastatic tumors. The Phase 2 Monotherapy part is an open-label, non-randomized, multicenter Simon's 2-stage design that investigates the safety, tolerability, and antitumor activity of STC-15 in participants with selected, relapsed sarcomas subtypes, dedifferentiated (DD) liposarcoma and leiomyosarcoma (uterine and non-uterine).
Protocol Amendment History 7 changes
notable Trial sites expanded: 6 -> 9 locations 2026-07-21
notable Trial sites expanded: 3 -> 6 locations 2026-04-18
critical Primary endpoint(s) modified 2026-04-07
notable Enrollment reduced: 188 -> 107 participants 2026-04-07
minor Trial arms changed: 5 -> 3 2026-04-07
notable Primary completion pushed: 2026-12-29 -> 2027-12-29 2026-04-07
minor Completion pushed: 2027-06-29 -> 2028-06-29 2026-04-07
Trial Details
NCT Number NCT06975293
Lead Sponsor STORM Therapeutics LTD
Collaborators: Coherus Oncology, Inc.
Conditions Solid Tumor, Sarcoma, Leiomyosarcoma, Dedifferentiated Liposarcoma
Enrollment 107 participants
Start Date 2025-05-05
Primary Completion 2027-12-29 (estimated)
Study Completion 2028-06-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-20