STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
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
1 other identifier
interventional
107
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2025
CompletedStudy Start
First participant enrolled
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 29, 2028
April 21, 2026
April 1, 2026
2.7 years
April 14, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Combination Cohorts: Safety and tolerability of STC-15 in combination with toripalimab
Incidence of adverse events graded according to CTCAE v5.0
6 months
Phase 2 Monotherapy Cohorts: Antitumor activity of STC-15 monotherapy
ORR according to RECIST
6 months
Secondary Outcomes (5)
Combination Cohorts: Anti-tumor activity
6 months
Combination and Phase 2 Monotherapy Cohorts: Maximum observed plasma concentration of STC-15 (Cmax)
22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated time to reach maximum observed plasma concentration (Tmax)
22 days
Combination and Phase 2 Monotherapy Cohorts: Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)
22 days
Phase 2 Monotherapy Cohorts: Safety and tolerability of STC-15
6 months
Study Arms (3)
Phase 1 dose escalation
EXPERIMENTALPhase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab
Phase 2 Stage 1 Monotherapy
EXPERIMENTALSTC-15 in patients with DD liposarcoma or leiomyosarcoma
Phase 2 Stage 2 Monotherapy
EXPERIMENTALSTC-15 in patients with DD liposarcoma or leiomyosarcoma
Interventions
STC-15 in combination with toripalimab in 21-day cycles
STC-15 monotherapy in 21-day cycles
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- STORM Therapeutics LTDlead
- Coherus Oncology, Inc.collaborator
Study Sites (6)
Northwell Health Cancer Institute
Lake Success, New York, 11042, United States
NEXT Houston
Houston, Texas, 77054, United States
NEXT Dallas
Irving, Texas, 75039, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
The START Center
San Antonio, Texas, 78229, United States
NEXT Oncology
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sandra Tong, MD
Storm Therapeutics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2025
First Posted
May 16, 2025
Study Start
May 5, 2025
Primary Completion (Estimated)
December 29, 2027
Study Completion (Estimated)
June 29, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04