NCT06975293

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

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: STORM Therapeutics LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumor
• Sarcoma
• Leiomyosarcoma
• Dedifferentiated Liposarcoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	STC-15 in combination with toripalimab	STC-15 in combination with toripalimab in 21-day cycles
DRUG	STC-15 monotherapy	STC-15 monotherapy in 21-day cycles

Timeline

• Start date: 2025-05-05
• Primary completion: 2027-12-29
• Completion: 2028-06-29
• First posted: 2025-05-16
• Last updated: 2026-04-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study