STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Key facts
- Where
- Boston, Cleveland, Fairfax, Grand Rapids, Houston, Irving, Lake Success, Miami, New York, San Antonio, San Francisco, and Seattle, United StatesSee the 14 sites
- Phase
- Phase 1/2
Where in United States
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
- NEXT OncologyFairfax, United StatesTaking people
- START | MidwestGrand Rapids, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesNot yet recruiting
- NEXT HoustonHouston, United StatesTaking people
- NEXT DallasIrving, United StatesTaking people
- Northwell Health Cancer InstituteLake Success, United StatesTaking people
- University of Miami - Sylvester Comprehensive Cancer CenterMiami, United StatesNot yet recruiting
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNot yet recruiting
- NEXT OncologySan Antonio, United StatesTaking people
- The START CenterSan Antonio, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- STORM Therapeutics LTD
- Trial code
- NCT06975293
- Record updated
- 22 October 2026
- Original 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.Read full original descriptionShow less
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
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).
Inclusion: 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; 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.
Exclusion: 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; Pregnant and lactating women.