Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 1:18 AM
Study NCT ID:
NCT06975293
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656314', 'term': 'toripalimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 188}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-04-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of STC-15 in combination with toripalimab', 'timeFrame': '6 months', 'description': 'Incidence of adverse events graded according to CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Anti-tumor activity', 'timeFrame': '6 months', 'description': 'To evaluate the antitumor activity of STC-15 in combination with toripalimab as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune RECIST (iRECIST) criteria'}, {'measure': 'Maximum observed plasma concentration of STC-15 (Cmax)', 'timeFrame': '22 days'}, {'measure': 'Recommended Phase 2 Dose', 'timeFrame': '6 months', 'description': 'Identification of a tolerable and safe dose for expansion cohorts based on dose limiting toxicities'}, {'measure': 'Calculated time to reach maximum observed plasma concentration (Tmax)', 'timeFrame': '22 days'}, {'measure': 'Calculated area under the plasma concentration-time curve of STC-15 (AUC0-t)', 'timeFrame': '22 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['STC-15', 'Toripalimab', 'PD1', 'Checkpoint Combination'], 'conditions': ['Metastatic Non-small Cell Lung Cancer', 'Metastatic Melanoma', 'Metastatic Endometrial Cancer', 'Metastatic Head-and-neck Squamous-cell Carcinoma', 'Solid Tumor']}, 'descriptionModule': {'briefSummary': "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).\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Estimated life expectancy ≥ 3 months.\n* ECOG performance status 0 or 1.\n* Measurable disease according to RECIST v1.1 as assessed by the local site investigator/radiology.\n* Documented radiologic assessment of progression on the prior therapy before study entry.\n* Have the ability to swallow, retain, and absorb oral medication.\n\nInclusion Criteria (Expansion):\n\n* 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.\n* 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.\n* 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\n* 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.\n\nKey Exclusion Criteria:\n\n* Pregnant and lactating women.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks prior to first IMP administration.\n* 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.\n* 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.\n* History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or the presence of ongoing pneumonitis/interstitial lung disease).\n* Clinically significant cardiovascular disease or condition.\n* Known active CNS metastases and/or leptomeningeal disease.'}, 'identificationModule': {'nctId': 'NCT06975293', 'briefTitle': 'STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'STORM Therapeutics LTD'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STC-15-24202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation', 'description': 'Phase 1b 3+3 trial design of dose escalation of STC-15 in combination with toripalimab', 'interventionNames': ['Combination Product: STC-15 in combination with toripalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose expansion NSCLC', 'description': 'STC-15 in combination with toripalimab (anti-PD-1) in locally advanced and unresectable or metastatic NSCLC', 'interventionNames': ['Combination Product: STC-15 in combination with toripalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose expansion melanoma', 'description': 'STC-15 in combination with toripalimab in locally advanced unresectable or metastatic melanoma', 'interventionNames': ['Combination Product: STC-15 in combination with toripalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose expansion endometrial cancers', 'description': 'STC-15 in combination with toripalimab in locally advanced unresectable or metastatic endometrial cancers', 'interventionNames': ['Combination Product: STC-15 in combination with toripalimab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose expansion HNSCC', 'description': 'STC-15 in combination with toripalimab in locally advanced or metastatic HNSCC', 'interventionNames': ['Combination Product: STC-15 in combination with toripalimab']}], 'interventions': [{'name': 'STC-15 in combination with toripalimab', 'type': 'COMBINATION_PRODUCT', 'description': 'STC-15 in combination with toripalimab in 21-day cycles', 'armGroupLabels': ['Dose escalation', 'Dose expansion HNSCC', 'Dose expansion NSCLC', 'Dose expansion endometrial cancers', 'Dose expansion melanoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dana Breashears', 'role': 'CONTACT', 'email': 'dbreashears@northwell.edu'}, {'name': 'Nicholas Honstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwell Health Cancer Institute', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Isabel Jimenez, RN, MSN', 'role': 'CONTACT', 'email': 'isabel.jimenez@startresearch.com', 'phone': '210-593-5265'}, {'name': 'Kyriakos Papadopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The START Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Blake Patterson', 'role': 'CONTACT', 'email': 'bpatterson@nextoncology.com', 'phone': '703-783-4505'}, {'name': 'M. Adham Salkeni, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'centralContacts': [{'name': 'Atif Abbas, MD', 'role': 'CONTACT', 'email': 'atif.abbas@stormtherapeutics.com', 'phone': '617-671-9779'}, {'name': 'Melinda Snyder', 'role': 'CONTACT', 'email': 'melinda.snyder@stormtherapeutics.com', 'phone': '617-233-4057'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'STORM Therapeutics LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Coherus Oncology, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}