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STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers

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

NCT06975293•STORM Therapeutics LTD

View on ClinicalTrials.gov

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 four different locally advanced unresectable or metastatic tumors such as indications: (1) in combination with toripalimab (anti- programmed cell death 1 \[PD-1\]) in locally advanced and unresectable or metastatic non-small cell lung cancer (NSCLC), (2) in combination with toripalimab in locally advanced unresectable or metastatic melanoma, (3) in combination with toripalimab in locally advanced unresectable or metastatic endometrial cancers, and (4) in combination with toripalimab in locally advanced or metastatic head and neck squamous cell carcinoma (HNSCC). This study comprises of 2 parts: a combination dose escalation part (Phase 1b) followed by an assessment of the combination treatment's antitumor activity (Phase 2). This study will be conducted in adult participants with advanced malignancies to characterize the safety, tolerability, PK, and clinical activity of STC-15 in combination with toripalimab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 the ability to swallow, retain, and absorb oral medication.
•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.

Exclusion Criteria

•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.

Locations (3)

Northwell Health Cancer Institute

Lake Success, New York, United States

The START Center

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

Key Dates

Start Date

May 5, 2025

Primary Completion Date

December 29, 2026

Completion Date

June 29, 2027

Last Updated

March 5, 2026

Enrollment

188

ESTIMATED participants

Conditions

Metastatic Non-small Cell Lung CancerMetastatic MelanomaMetastatic Endometrial CancerMetastatic Head-and-neck Squamous-cell CarcinomaSolid Tumor

Interventions

STC-15 in combination with toripalimab

COMBINATION_PRODUCT

Contacts

Atif Abbas, MD

CONTACT

617-671-9779 atif.abbas@stormtherapeutics.com

Melinda Snyder

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers

Inclusion Criteria

Exclusion Criteria

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