STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers
NCT ID: NCT06975293
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
188 participants
INTERVENTIONAL
2025-05-05
2026-01-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation
Phase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab
STC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
Dose expansion NSCLC
STC-15 in combination with toripalimab (anti-PD-1) in locally advanced and unresectable or metastatic NSCLC
STC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
Dose expansion melanoma
STC-15 in combination with toripalimab in locally advanced unresectable or metastatic melanoma
STC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
Dose expansion endometrial cancers
STC-15 in combination with toripalimab in locally advanced unresectable or metastatic endometrial cancers
STC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
Dose expansion HNSCC
STC-15 in combination with toripalimab in locally advanced or metastatic HNSCC
STC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
Interventions
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STC-15 in combination with toripalimab
STC-15 in combination with toripalimab in 21-day cycles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Coherus Oncology, Inc.
INDUSTRY
STORM Therapeutics LTD
INDUSTRY
Responsible Party
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Locations
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Northwell Health Cancer Institute
Lake Success, New York, United States
The START Center
San Antonio, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STC-15-24202
Identifier Type: -
Identifier Source: org_study_id
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