RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: STORM Therapeutics LTD • ClinicalTrials.gov ID: NCT06975293

Registry updated: 2026-10-20

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Description

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).

Interventions

STC-15 in combination with toripalimab (Drug)
STC-15 in combination with toripalimab in 21-day cycles
STC-15 monotherapy (Drug)
STC-15 monotherapy in 21-day cycles

Eligibility criteria

Key Inclusion Criteria: * Estimated life expectancy ≥ 3 months. * ECOG performance status 0 or 1. * Measurable disease according to RECIST v1.1 as assessed by the local site investigator/radiology. * Documented radiologic assessment of progression on the prior therapy before study entry. * Have adequate organ function. * Have the ability to swallow, retain, and absorb oral medication. Inclusion Criteria (Phase 2 Monotherapy Cohorts): * Have histologic or cytologic confirmation of advanced sarcoma of the selected histologic subtype that is not amenable to local curative therapy. Participant must have received at least 2, but no more than 4 prior lines of systemic therapy. * Pre-treatment and on-treatment biopsy if medically feasible. Key Exclusion Criteria: * Pregnant and lactating women. * Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to first IMP administration. * Participants who have not recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline, according to NCI-CTCAE v5.0. Exceptions include: alopecia, Grade ≤ 2 neuropathy, and endocrine-related AEs Grade ≤ 2 who are stable on treatment or hormone replacement. * History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or the presence of ongoing pneumonitis/interstitial lung disease). * Clinically significant cardiovascular disease or condition. * Known active CNS metastases and/or leptomeningeal disease.

Conditions

Solid Tumor Sarcoma Leiomyosarcoma Dedifferentiated Liposarcoma

Locations

University of California, San Francisco — San Francisco, California, United States
University of Miami-Sylvester Comprehensive Cancer Center — Miami, Florida, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
START Midwest — Grand Rapids, Michigan, United States
Northwell Health Cancer Institute — Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
MD Anderson Cancer Center — Houston, Texas, United States
NEXT Houston — Houston, Texas, United States
NEXT Dallas — Irving, Texas, United States
NEXT Oncology — San Antonio, Texas, United States
The START Center — San Antonio, Texas, United States
NEXT Oncology — Fairfax, Virginia, United States
Fred Hutchinson Cancer Center — Seattle, Washington, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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