Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-06 @ 5:56 AM
Study NCT ID:
NCT06963502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 762}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Event(s) (AEs)', 'timeFrame': 'From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).', 'description': 'Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).ORR by the Investigator According to RECIST v1.1'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).', 'description': 'Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD).DCR by the Investigator According to RECIST v1.1'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Time from Cycle 1 Day 1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, up to 2 years (each cycle is 14 days).', 'description': 'TTR by the Investigator According to RECIST v1.1'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years', 'description': 'DOR by the Investigator According to RECIST v1.1'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years', 'description': 'PFS by the Investigator According to RECIST v1.1'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Cycle 1 Day 1 to date of death from any cause, up to 5 years (each cycle is 14 days)', 'description': 'Defined as the time from C1D1 to death from any cause by the Investigator According to RECIST v1.1'}, {'measure': 'Plasma Concentrations of HS-10370', 'timeFrame': 'Cycle 1 Day 1 to date of death from any cause. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation, up to 2 years. (each cycle is 14 days)', 'description': 'Defined as the time from C1D1 to death from any cause'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days)', 'description': 'Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data.'}, {'measure': 'Time of maximum concentration (Tmax)', 'timeFrame': 'Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days)', 'description': 'Tmax is defined as the time required for a drug to reach peak concentration in plasma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors', 'Colorectal Cancer', 'Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women greater than or equal to 18 years\n* At least one measurable lesion in accordance with RECIST 1.1\n* Must have an ECOG performance status of 0 or 1.\n* Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.\n* Documentation of the presence of a KRAS G12C mutation\n* Estimated life expectancy ≥12 weeks.\n* Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.\n* The subjects are able to comply with the process of the protocol.\n\nExclusion Criteria:\n\n* Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.\n* Active brain metastases.\n* Patients with uncontrolled pleural, ascites or pericardial effusion\n* Spinal cord compression\n* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.\n* Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ functions.\n* Abnormal cardiac examination results.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Diabetes ketoacidosis or hyperglycemia hyperosmolality\n* Uncontrolled hypertension.\n* Severe bleeding symptoms or bleeding tendencies.\n* Severe arteriovenous thrombosis occurred\n* Serious infection.\n* Continuous use of glucocorticoids\n* Active infectious diseases.\n* Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications\n* Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.\n* Interstitial lung disease (ILD).\n* Serious neurological or mental disorders.\n* Active autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT06963502', 'briefTitle': 'A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ib Study Evaluating the Safety, Tolerability , Pharmacokinetics，Activity and Immunogenicity of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'HS-10370-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1:HS-10370 dose 1+ HS-20117 dose 3', 'interventionNames': ['Drug: HS-10370', 'Drug: HS-20117']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab', 'interventionNames': ['Drug: HS-10370', 'Drug: HS-20117', 'Drug: Adebrelimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy', 'interventionNames': ['Drug: HS-10370', 'Drug: HS-20117', 'Drug: Capecitabine', 'Drug: Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy', 'interventionNames': ['Drug: HS-10370', 'Drug: HS-20117', 'Drug: Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5', 'interventionNames': ['Drug: HS-10370', 'Drug: HS-20117', 'Drug: HS-20093']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab', 'interventionNames': ['Drug: HS-10370', 'Drug: Adebrelimab', 'Drug: HS-20093']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy', 'interventionNames': ['Drug: HS-10370', 'Drug: Adebrelimab', 'Drug: HS-20093', 'Drug: platinum (cisplatin or carboplatin)']}], 'interventions': [{'name': 'HS-10370', 'type': 'DRUG', 'description': 'Participants will receive HS-10370 dose 1 administered orally', 'armGroupLabels': ['Arm 1:HS-10370 dose 1+ HS-20117 dose 3', 'Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab', 'Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy', 'Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy', 'Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5', 'Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab', 'Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy']}, {'name': 'HS-20117', 'type': 'DRUG', 'description': 'Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.', 'armGroupLabels': ['Arm 1:HS-10370 dose 1+ HS-20117 dose 3', 'Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab', 'Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy', 'Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy', 'Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5']}, {'name': 'Adebrelimab', 'type': 'DRUG', 'description': 'Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle', 'armGroupLabels': ['Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab', 'Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab', 'Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Participants will receive Capecitabine administered orally', 'armGroupLabels': ['Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.', 'armGroupLabels': ['Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy']}, {'name': 'Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan', 'type': 'DRUG', 'description': 'Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.', 'armGroupLabels': ['Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy']}, {'name': 'HS-20093', 'type': 'DRUG', 'description': 'Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle', 'armGroupLabels': ['Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5', 'Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab', 'Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy']}, {'name': 'platinum (cisplatin or carboplatin)', 'type': 'DRUG', 'description': 'Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles.', 'armGroupLabels': ['Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'contacts': [{'name': 'Xia Liu', 'role': 'CONTACT', 'email': 'hrec2013@126.com', 'phone': '(0086)0571-87783508'}, {'name': 'Ying Yuan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Xuzhi Pan', 'role': 'CONTACT', 'email': 'llwyh@sysucc.org.cn', 'phone': '020-87343009'}, {'name': 'Ruihua Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}