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 San Francisco, California.

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

First listed
May 16, 2025
Start date
May 5, 2025
Status verified
Aug 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 (10)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Lisa Tan
[email protected]
415-866-7866
Varun Monga, MBBS (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Andrew J Wagner, MD, PhD
[email protected]
877-338-7425
Andrew J Wagner, MD, PhD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546
Ronan Pleass
[email protected]
616-954-5554
Andrew Sochacki, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health Cancer InstituteLake SuccessNew York11042
Serena Petruzzelli
[email protected]
Anthony Philip, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Sarcoma Research Team
[email protected]
(713) 792-3626
Elise Nassif, MD (PRINCIPAL_INVESTIGATOR)
NEXT HoustonHoustonTexas77054
Emma Morales
[email protected]
832-384-7912
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
NEXT DallasIrvingTexas75039
Aislyn Morales
[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)

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CADana Farber Cancer Institute· Boston, MASTART Midwest· Grand Rapids, MINorthwell Health Cancer Institute· Lake Success, NYMD Anderson Cancer Center· Houston, TXNEXT Houston· Houston, TX

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