Status:
RECRUITING
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers
Lead Sponsor:
STORM Therapeutics LTD
Collaborating Sponsors:
Coherus Oncology, Inc.
Conditions:
Metastatic Non-small Cell Lung Cancer
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 toripalima...
Eligibility Criteria
Inclusion
- Key
- 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 the ability to swallow, retain, and absorb oral medication.
- Inclusion Criteria (Expansion):
- NSCLC (when applicable): Participants with AGAs (actionable genetic alterations) must have received targeted therapy unless contraindicated. Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy. Participants must have disease progression on prior anti-PD-1/L1.
- HNSCC (when applicable): Participants must have progressed on following prior lines: 2L or 3L recurrent/metastatic disease; regardless of PD-L1 score. Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy.
- Endometrial (when applicable): Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy. Participants must have disease progression on prior anti-PD-1/L1
- Melanoma (when applicable): Participants must not have received more than three previous lines of systemic treatment for unresectable locally advanced or metastatic disease. This must include at least a prior anti-PD-1/L1 alone or in combination with chemotherapy. Participants must have disease progression on prior anti-PD-1/L1.
- Key
Exclusion
- Pregnant and lactating women.
- Received prior systemic anticancer therapy including investigational agents within 4 weeks 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.
- Major surgery less than 4 weeks prior to the first IMP administration or participants who have not recovered from the side effects of the surgery.
- 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.
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2026
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06975293
Start Date
May 5 2025
End Date
January 29 2026
Last Update
July 10 2025
Active Locations (3)
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1
Northwell Health Cancer Institute
Lake Success, New York, United States, 11042
2
The START Center
San Antonio, Texas, United States, 78229
3
NEXT Oncology
Fairfax, Virginia, United States, 22031