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
STORM Therapeutics LTD
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
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- Combination ProductSTC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
- DrugSTC-15 monotherapy
STC-15 monotherapy in 21-day cycles
Locations (6)
- Northwell Health Cancer InstituteLake Success, New York
- NEXT HoustonHouston, Texas
- NEXT DallasIrving, Texas
- NEXT OncologySan Antonio, Texas
- The START CenterSan Antonio, Texas
- NEXT OncologyFairfax, Virginia