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Clinical Trials in the USA / NCT06975293
Recruiting Phase 1/2

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

NCT06975293 · tracked via the Priya Life Science USA tracker
Sponsor
STORM Therapeutics LTD
Phase
Phase 1/2
Started
2025-05-05
Last updated
2026-08-25

Condition(s) studied

Solid TumorSarcomaLeiomyosarcomaDedifferentiated Liposarcoma

Investigational drug(s) / intervention(s)

STC-15 in combination with toripalimabSTC-15 monotherapy

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
University of California, San Francisco San Francisco California Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
START Midwest Grand Rapids Michigan Recruiting
Northwell Health Cancer Institute Lake Success New York 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

Other trials for the same condition

Official registry record

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