STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Condition(s) studied
Investigational drug(s) / intervention(s)
STC-15 in combination with toripalimab: STC-15 in combination with toripalimab in 21-day cycles
STC-15 monotherapy: STC-15 monotherapy in 21-day cycles
Study 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
Primary outcome measure(s)
- Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab — 6 months
Incidence of adverse events graded according to CTCAE v5.0 - Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy — 6 months
ORR according to RECIST
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, San Francisco | San Francisco | California | Recruiting |
| University of Miami-Sylvester Comprehensive Cancer Center | Miami | Florida | Not Yet Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| START Midwest | Grand Rapids | Michigan | Recruiting |
| Northwell Health Cancer Institute | Lake Success | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Not Yet Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Not Yet Recruiting |
| NEXT Houston | Houston | Texas | Recruiting |
| NEXT Dallas | Irving | Texas | Recruiting |
| NEXT Oncology | San Antonio | Texas | Recruiting |
| The START Center | San Antonio | Texas | Recruiting |
| NEXT Oncology | Fairfax | Virginia | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06975293 on ClinicalTrials.gov ↗ ← All trials in the USA