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This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI363 | Experimental | IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI363 | Drug | IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | Up to 90 days post last dose | |
| Dose-limiting Toxicity (DLT) | The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Guo | Contact | 1-832-207-5244 | amanda.guo@innoventbio.com | |
| William Liu | Contact | 1-917-436-6817 | william.liu01@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco (UCSF) | Recruiting | San Francisco | California | 94143 | United States |
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| Ocala Oncology Center | Recruiting | Ocala | Florida | 34474 | United States |
|
| BRCR Medical Center | Recruiting | Plantation | Florida | 33322 | United States |
|
| University of Kansas Medical Center (KUMC) | Recruiting | Fairway | Kansas | 66205 | United States |
|
| Michigan Hematology & Oncology Consultants - MedOnc Dearborn | Recruiting | Dearborn | Michigan | 48126 | United States |
|
| Michigan Hematology & Oncology Consultants - MedOnc Troy | Recruiting | Troy | Michigan | 48098 | United States |
|
| MD Anderson Cancer Center-University of Texas | Recruiting | Houston | Texas | 77025 | United States |
|
| Oncology Consultants P.A. | Recruiting | Houston | Texas | 77030 | United States |
|
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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