Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04162327
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2019-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-11-11', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate the efficacy in participants with different expression level of HER2 in tumor tissue', 'timeFrame': 'up to 9 months'}, {'measure': 'Evaluate the efficacy in participants with different expression level of PD-L1 in tumor tissue', 'timeFrame': 'up to 9 months'}, {'measure': 'Evaluate the efficacy in participants with different expression level of tumor infiltrating lymphocyte (TILs)', 'timeFrame': 'up to 9 months'}, {'measure': 'Evaluate the efficacy in participants with different subtype of immune cells in peripheral blood', 'timeFrame': 'up to 9 months'}], 'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve (AUC)', 'timeFrame': 'up to 9 months'}, {'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'up to 9 months'}, {'measure': 'Terminal elimination half-life (T1/2)', 'timeFrame': 'up to 9 months'}, {'measure': 'Apparent volume of distribution (Vd)', 'timeFrame': 'up to 9 months'}], 'secondaryOutcomes': [{'measure': 'Evaluate receptor occupancy (RO) following single-dose or multi-dose of IBI315', 'timeFrame': 'up to 9 months'}, {'measure': 'The percentage of participants with anti-drug antibody (ADA) positive after dosing IBI315', 'timeFrame': 'up to 9 months'}, {'measure': 'The percentage of participants with neutralizing antibody (NAb) positive after dosing IBI315', 'timeFrame': 'up to 9 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors', 'detailedDescription': 'This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written (signed) informed consent.\n* Life expectancy ≥12 weeks.\n* Patients with HER2-expressing advanced solid tumor who failed on current standard of care\n* According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.\n* ECOG performance status 0-1.\n* Adequate organ and marrow function evaluated by laboratory tests as follow:\n\n * CBC: absolute neutrophil count (ANC) ≥ 1.0×109/L (Ia stage) or 1.5×109/L (Ib stage); Platelet (PLT) ≥ 75×109/L; Hemoglobin (HGB) ≥ 9.0g/L;\n * Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal value (ULN) for patients without hepatic metastases, ≤ 2×ULN for patients with hepatic metastases or Gilbert syndrome; Alanine aminotransferase (ALT) ≤ 2.5×ULN; Aspartate transferase (AST) ≤ 2.5×ULN;\n * Renal function: Clearance of creatinine (CCr) by Cockcroft-Gault formula or 24-hour urine collection ≥ 50ml/min;\n * Urinalysis: urine protein \\< 2+ or urine protein in 24-hour urine collection \\< 1g;\n * Coagulation function: activated partial thromboplastin time (APTT）≤ 1.5×ULN; international normalized ratio (INR）≤ 1.5\n* left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;\n* Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2;\n* Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment.\n* Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood.\n\nExclusion Criteria:\n\n* Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue;\n* Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation;\n* Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy;\n* CNS metastasis, spinal compression, or carcinomatous meningitis\n* Active autoimmune disease or inflammatory disorders.\n* Primary immunodeficiency diseases;\n* Pregnant or breast-feeding female.'}, 'identificationModule': {'nctId': 'NCT04162327', 'briefTitle': 'A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Phase Ia/Ib, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI315, an Anti-HER2/PD-1 Bi-specific Antibody in Patients With HER2-expressing Advanced Solid Tumor', 'orgStudyIdInfo': {'id': 'CIBI315A101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ia stage - IBI315 Dose escalation', 'interventionNames': ['Drug: IBI315']}, {'type': 'EXPERIMENTAL', 'label': 'Ib stage - IBI315 monotherapy', 'interventionNames': ['Drug: IBI315']}], 'interventions': [{'name': 'IBI315', 'type': 'DRUG', 'description': 'Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.', 'armGroupLabels': ['Ia stage - IBI315 Dose escalation']}, {'name': 'IBI315', 'type': 'DRUG', 'description': 'Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue.', 'armGroupLabels': ['Ib stage - IBI315 monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': "The 307th Hospital of Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}