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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllSTORM Therapeutics LTD
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Estimated life expectancy โ‰ฅ 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 โ‰ค 1 or baseline, according to NCI-CTCAE v5.0. Exceptions include: alopecia, Grade โ‰ค 2 neuropathy, and endocrine-related AEs Grade โ‰ค 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.
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What it tests

  • STC-15 in combination with toripalimab
  • STC-15 monotherapy
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Where

14 sites
University of California, San Francisco
San Francisco, United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, United States
Dana Farber Cancer Institute
Boston, United States
START Midwest
Grand Rapids, United States
Northwell Health Cancer Institute
Lake Success, United States
Memorial Sloan Kettering Cancer Center
New York, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
MD Anderson Cancer Center
Houston, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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