Combining STC-15 with Toripalimab for Advanced Cancers

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 study is testing whether combining a new cancer drug, STC-15, with toripalimab can help people with advanced cancers feel better and improve their treatment outcomes.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: STORM Therapeutics LTD (industry)
• Drugs / interventions: toripalimab
• Locations: 6 sites (Lake Success, New York and 5 other locations)
• Trial ID: NCT06975293 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced or metastatic non-small cell lung cancer, melanoma, endometrial cancer, or head-and-neck squamous cell carcinoma who have experienced disease progression on prior treatments.

Not a fit: Patients who have not received prior anti-PD-1 therapy or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are resistant to current therapies.

How similar studies have performed: Other studies combining PD-1 inhibitors with novel agents have shown promising results, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Lake Success, New York and 5 other locations

• Northwell Health Cancer Institute — Lake Success, New York, United States (RECRUITING)
• NEXT Houston — Houston, Texas, United States (RECRUITING)
• NEXT Dallas — Irving, Texas, United States (RECRUITING)
• NEXT Oncology — San Antonio, Texas, United States (RECRUITING)
• The START Center — San Antonio, Texas, United States (RECRUITING)
• NEXT Oncology — Fairfax, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Sandra Tong, MD

Conditions: Solid Tumor, Sarcoma, Leiomyosarcoma, Dedifferentiated Liposarcoma, STC-15, Toripalimab, PD1, Checkpoint Combination