STC-15 with Toripalimab for Advanced Cancers and STC-15 Monotherapy for Sarcomas

This study is testing STC-15, a new medication, in two ways. For certain advanced cancers, STC-15 is given along with toripalimab. For specific types of sarcoma (a cancer that starts in tissues like bone or muscle), including dedifferentiated liposarcoma and leiomyosarcoma, STC-15 is given alone. The main goals are to see how safe these treatments are and if they help shrink tumors. You might be able to join if you are at least 18 years old, have a good general health status (ECOG performance status 0 or 1), and your cancer has progressed on prior treatments. The study aims to enroll 107 participants.

Study design
This is an early phase interventional study. The monotherapy part for sarcomas is open-label, meaning you and your doctors will know which treatment you are receiving, and it is not randomized.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and tumor activity at 6 months for different parts of the trial.

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NCT06975293

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
STORM Therapeutics LTD
~107 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:STC-15 in combination with toripalimabSTC-15 monotherapy

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab
Measured over 6 months
+1 more outcome measured
Solid Tumor
Sarcoma
Leiomyosarcoma
Dedifferentiated Liposarcoma
10 sites across 6 states
Texas5
California1
Massachusetts1
Michigan1
New York1
Virginia1
  • Sandra Tong, MD · STUDY_DIRECTOR · Storm Therapeutics

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
  • Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab6 months

    Incidence of adverse events graded according to CTCAE v5.0

  • Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy6 months

    ORR according to RECIST