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

Part of paid clinical trials in Lake Success, New York.

Sponsor
STORM Therapeutics LTD
Study ID
NCT06975293
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Dedifferentiated Liposarcoma
  • Leiomyosarcoma
  • Sarcoma
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STC-15 in combination with toripalimab — COMBINATION_PRODUCT
    STC-15 in combination with toripalimab in 21-day cycles
  • STC-15 monotherapy — DRUG
    STC-15 monotherapy in 21-day cycles

Study Details

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).

Key Dates

Start date
May 5, 2025
Status verified
Apr 2026
Primary completion
Dec 29, 2027
Completion
Jun 29, 2028

Study Design

Enrollment
107 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 dose escalation
    Phase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab
  • Experimental: Phase 2 Stage 1 Monotherapy
    STC-15 in patients with DD liposarcoma or leiomyosarcoma
  • Experimental: Phase 2 Stage 2 Monotherapy
    STC-15 in patients with DD liposarcoma or leiomyosarcoma

Primary Outcome Measure

Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab [ Time Frame: 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Northwell Health Cancer InstituteLake SuccessNew York11042
Serena Petruzzelli
[email protected]
Anthony Philip, MD (PRINCIPAL_INVESTIGATOR)
NEXT HoustonHoustonTexas77054
Emma Morales
[email protected]
832-384-7912
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
NEXT DallasIrvingTexas75039
Mofopefoluwa Akinwale
[email protected]
972-893-8800
Faran Polani, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Jordan Georg
[email protected]
210-580-9521
Ildefonso I Rodriguez Rivera, MD (PRINCIPAL_INVESTIGATOR)
The START CenterSan AntonioTexas78229
Isabel Jimenez, RN, MSN
[email protected]
210-593-5265
Kyriakos Papadopoulos, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologyFairfaxVirginia22031
Blake Patterson
[email protected]
703-783-4505
M. Adham Salkeni, MD, FRCPC (PRINCIPAL_INVESTIGATOR)

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Northwell Health Cancer Institute· Lake Success, NYNEXT Houston· Houston, TXNEXT Dallas· Irving, TXNEXT Oncology· San Antonio, TXThe START Center· San Antonio, TXNEXT Oncology· Fairfax, VA

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