Combining STC-15 with Toripalimab for Advanced Cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and effectiveness of STC-15, a METTL3 inhibitor, when used alongside toripalimab, an anti-PD-1 therapy, in patients with advanced or metastatic cancers including non-small cell lung cancer, melanoma, endometrial cancer, and head-and-neck squamous cell carcinoma. The study is divided into two phases: a dose escalation phase to determine the optimal dosage and a subsequent phase to assess the treatment's antitumor activity. Participants will be closely monitored for safety and response to the combination therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Northwell Health Cancer Institute
  Lake Success, New York, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• NEXT Houston
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Sandra Tong, MD
• Email: sandy.tong@stormtherapeutics.com
• Phone: 650-399-6357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.