Recruiting
Phase 1
Phase 2

STC-15 & Toripalimab

Sponsor:

STORM Therapeutics LTD

Code:

NCT06975293

Conditions

Solid Tumor

Sarcoma

Leiomyosarcoma

Dedifferentiated Liposarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STC-15 in combination with toripalimab

STC-15 monotherapy

Study Details

Brief 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).

Conditions

Solid Tumor

Sarcoma

Leiomyosarcoma

Dedifferentiated Liposarcoma

Study ID

NCT06975293

Start date

May 5, 2025

Status verified date

Aug, 2026

Completion date

Jun 29, 2028

Anticipated

Primary completion date

Dec 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

107 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

STC-15 in combination with toripalimab

STC-15 in combination with toripalimab in 21-day cycles

STC-15 monotherapy

STC-15 monotherapy in 21-day cycles

Primary outcome measure

  • Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab [ Time Frame: 6 months ]
  • Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sandra Tong, MD

650-399-6357sandy.tong@stormtherapeutics.com

Melinda Snyder

617-233-4057melinda.snyder@stormtherapeutics.com

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Lisa Tan

415-866-7866Lisa.tan@ucsf.edu

Principal Investigator:

Varun Monga, MBBS

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Andrew J Wagner, MD, PhD

877-338-7425Andrew_wagner@dfci.harvard.edu

Principal Investigator:

Andrew J Wagner, MD, PhD

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Ronan Pleass

616-954-5554ronan.pleass@startresearch.com

Principal Investigator:

Andrew Sochacki, MD

Northwell Health Cancer Institute

Recruiting

Lake Success, New York, United States, 11042

Contacts

Serena Petruzzelli

spetruzzelli@northwell.edu

Principal Investigator:

Anthony Philip, MD

NEXT Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

832-384-7912emorales@nextoncology.com

Principal Investigator:

Jennifer Segar, MD

NEXT Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

Aislyn Morales

972 893 8800amorales@nextoncology.com

Principal Investigator:

Faran Polani, MD

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

210 580 9521jgeorg@nextoncology.com

Principal Investigator:

Ildefonso I Rodriguez Rivera, MD

The START Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Isabel Jimenez, RN, MSN

210-593-5265isabel.jimenez@startresearch.com

Principal Investigator:

Kyriakos Papadopoulos, MD

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

(703) 783-4505bpatterson@nextoncology.com

Principal Investigator:

M. Adham Salkeni, MD, FRCPC

More Information

Sponsor

STORM Therapeutics LTD

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • STC-15
  • Toripalimab
  • PD1
  • Checkpoint Combination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by STORM Therapeutics LTD on 2026-08-25.