RecruitingPhase 1Phase 2NCT06975293

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

Sponsor

STORM Therapeutics LTD

Enrollment

107 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

Sarcoma Solid Tumor Leiomyosarcoma Dedifferentiated Liposarcoma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing STC-15, a new oral drug that may help the immune system recognize and fight cancer, in combination with toripalimab (an immunotherapy drug) in people with various types of advanced cancer that have not responded to prior treatments. **You may be eligible if...** - You have advanced or metastatic cancer with measurable tumors - Your cancer has progressed on prior therapy - You are physically well (ECOG 0 or 1) - You have a life expectancy of at least 3 months - You can swallow and absorb oral medications **You may NOT be eligible if...** - Your cancer has active, uncontrolled brain metastases - You have serious autoimmune disease or are on immunosuppressants - You are pregnant or breastfeeding - You have had more than three prior lines of treatment (for certain cancer types) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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