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Recruiting NCT06975293

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

Phase I / Phase II Interventional Solid Tumor Sarcoma Leiomyosarcoma Dedifferentiated Liposarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STC-15 in combination with toripalimab, STC-15 monotherapy.
Who it may be relevant to
Registry conditions: Solid Tumor, Sarcoma, Leiomyosarcoma, Dedifferentiated Liposarcoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Combination product STC-15 in combination with toripalimab
    STC-15 in combination with toripalimab in 21-day cycles
  • Drug STC-15 monotherapy
    STC-15 monotherapy in 21-day cycles

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • 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

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • University of California, San Francisco — San Francisco
  • Dana Farber Cancer Institute — Boston
  • Northwell Health Cancer Institute — Lake Success
  • MD Anderson Cancer Center — Houston
  • NEXT Houston — Houston
  • NEXT Dallas — Irving
  • NEXT Oncology — San Antonio
  • The START Center — San Antonio
  • … and 1 more center

Identifiers

NCT: NCT06975293 · STC-15-24202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗