STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
NCT06975293 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2026-04-21
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
- 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
Sponsors & Collaborators
-
Coherus Oncology, Inc.
collaborator INDUSTRY -
STORM Therapeutics LTD
lead INDUSTRY
Principal Investigators
-
Sandra Tong, MD · Storm Therapeutics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-05
- Primary Completion
- 2027-12-29
- Completion
- 2028-06-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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