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The goal of this open-label, dose escalation and dose expansion Phase I clinical trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGC515 administered once daily in 3 weeks cycles in solid tumor patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | BGC515 Capsules will be administered orally in 21 day cycles, once daily (QD). Patients will be enrolled into escalating dose levels during the Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose(s) for Expansion (RDE). |
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| Dose Expansion | Experimental | BGC515 Capsules will be administered orally in 21 day cycles at MTD/RDE defined dose,once daily (QD), in patients with malignant mesothelioma (MM), epithelioid hemangioendothelioma (EHE), or other advanced solid tumors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGC515 | Drug | Capsules for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs). | AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. AE evaluation will be based on laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram, etc. | Through study completion, approximately 1 year. |
| Dose-limiting toxicities (DLTs) | DLT refers to the pre-specified AEs that occurred within 24 days after the first dose of study drug. | Within 24 days after the first dose of study drug. |
| Objective response rate (ORR) | Defined as the percentage of participants having complete response (CR) or partial response (PR). Evaluated by the Investigator based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. | Through study completion, approximately 3 years. |
| Progress-free survival(PFS) | Defined as the time interval between the first dose of the treatment and the first documented disease progression or death due to any cause (whichever occurs first). Evaluated by the Investigator based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. | Through study completion, approximately 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax). | Cmax of BGC515 in plasma. | Multiple time points, up to approximately 1 year. |
| Time to peak concentration (Tmax). | Tmax of BGC515 in plasma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BridGene Biosciences | Contact | 408-498-8127 | clinical@bridgenebiosciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D018323 | Hemangioendothelioma, Epithelioid |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Sequential Assignment
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| Multiple time points, up to approximately 1 year. |
| Half-life (t1/2). | t1/2 of BGC515 in plasma. | Multiple time points, up to approximately 1 year. |
| Area under the concentration-time curve from time zero to the last detectable plasma concentration (AUC0-t). | (AUC0-t) of BGC515 in plasma. | Multiple time points, up to approximately 1 year. |
| D018301 |
| Neoplasms, Mesothelial |
| D006390 | Hemangioendothelioma |
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |