Actively Recruiting
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Led by STORM Therapeutics LTD · Updated on 2026-04-21
107
Participants Needed
6
Research Sites
164 weeks
Total Duration
On this page
Sponsors
S
STORM Therapeutics LTD
Lead Sponsor
C
Coherus Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Estimated life expectancy 63 3 months
- ECOG performance status 0 or 1
- Measurable disease according to RECIST v1.1
- Documented progression on prior therapy before study entry
- Adequate organ function
- Ability to swallow, retain, and absorb oral medication
- For Phase 2 Monotherapy: histologic or cytologic confirmation of advanced sarcoma subtype not amenable to local curative therapy
- Received at least 2 but no more than 4 prior lines of systemic therapy
- Pre-treatment and on-treatment biopsy if medically feasible
You will not qualify if you...
- Pregnant and lactating women
- Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives before first IMP administration
- Not recovered from previous therapy adverse events to Grade 64 1 or baseline (exceptions: alopecia, Grade 64 2 neuropathy, stable endocrine-related AEs Grade 64 2)
- History or ongoing non-infectious pneumonitis/interstitial lung disease requiring steroids
- Clinically significant cardiovascular disease or condition
- Known active CNS metastases and/or leptomeningeal disease
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Northwell Health Cancer Institute
Lake Success, New York, United States, 11042
Actively Recruiting
2
NEXT Houston
Houston, Texas, United States, 77054
Actively Recruiting
3
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
4
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
5
The START Center
San Antonio, Texas, United States, 78229
Actively Recruiting
6
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sandra Tong, MD
CONTACT
M
Melinda Snyder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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