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This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BA1302 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BA1302 | Drug | BA1302 administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities | Up to 21 days | |
| adverse events | Through 28 days after the last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) | Up to approximately 1 years | |
| AUC from time zero to infinity (AUC0-inf) | Up to approximately 1 years |
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Inclusion Criteria:
1. Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.
2.Participants should be able to provide adequate tumor tissue for biomarker analysis
3.ECOG Performance Status ≤ 1.
4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| primary investigator | Contact | 13911233048 | Guoj307@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Maximum serum concentration (Cmax) | Up to approximately 1 years |
| Elimination half-life (t1/2) | Up to approximately 1 years |
| Area under the concentration-time curve (AUC) at steady state | Up to approximately 1 years |
| Incidence of anti-drug antibodies (ADA) | Up to approximately 1 years |
| Objective response rate (ORR) | Up to approximately 1 years |
| Duration of objective response (DOR) | Up to approximately 1 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |