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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06975293Sponsor: STORM Therapeutics LTDLast updated: 2026-04-21

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).

Arms & 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

Outcome measures

Primary

  • Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab

    Incidence of adverse events graded according to CTCAE v5.0

    Time frame: 6 months

  • Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy

    ORR according to RECIST

    Time frame: 6 months

Secondary

  • Combination Cohorts: Anti-tumor activity

    Time frame: 6 months

  • Combination and Phase 2 Monotherapy Cohorts: Maximum observed plasma concentration of STC-15 (Cmax)

    Time frame: 22 days

  • Combination and Phase 2 Monotherapy Cohorts: Calculated time to reach maximum observed plasma concentration (Tmax)

    Time frame: 22 days

  • Combination and Phase 2 Monotherapy Cohorts: Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)

    Time frame: 22 days

  • Phase 2 Monotherapy Cohorts: Safety and tolerability of STC-15

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (6)

Northwell Health Cancer Institute

Lake Success, New York, 11042

Recruiting
Serena Petruzzelli · Contact
Anthony Philip, MD · Principal Investigator

NEXT Houston

Houston, Texas, 77054

Recruiting
Jennifer Segar, MD · Principal Investigator

NEXT Dallas

Irving, Texas, 75039

Recruiting
Mofopefoluwa Akinwale · Contact
Faran Polani, MD · Principal Investigator

NEXT Oncology

San Antonio, Texas, 78229

Recruiting
Ildefonso I Rodriguez Rivera, MD · Principal Investigator

The START Center

San Antonio, Texas, 78229

Recruiting
Isabel Jimenez, RN, MSN · Contact
Kyriakos Papadopoulos, MD · Principal Investigator

NEXT Oncology

Fairfax, Virginia, 22031

Recruiting
Blake Patterson · Contact
M. Adham Salkeni, MD, FRCPC · Principal Investigator