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This study is to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of BGM-2121 in adult patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGM-2121 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM-2121 | Drug | BGM-2121 treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | Number and type of DLTs observed following administration of BGM-2121 at different dose levels, assessed according to protocol-defined criteria. | From first dose through the DLT evaluation period (28 days) |
| Treatment Discontinuation Due to Drug-Related Adverse Events | Number of participants who permanently discontinue BGM-2121 due to drug-related adverse events, graded per CTCAE v5.0. | From first dose through study completion, an average of 1 year |
| Incidence of Treatment-Emergent and Treatment-Related Adverse Events | Incidence, type, and timing of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs), graded per CTCAE v5.0. | From first dose through 6 weeks after the last dose of study treatment |
| Number of Participants With Grade ≥3 Laboratory Abnormalities | Number of participants experiencing Grade 3 or higher laboratory abnormalities, including hematology and serum chemistry parameters, based on CTCAE v5.0 criteria | From first dose through study completion, an average of 1 year |
| Changes in Electrocardiogram (ECG) Parameters | Change from baseline in ECG parameters, including QT/QTc interval, PR interval, and QRS duration. | From baseline through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Maximum Tolerated Dose (MTD) to establish RP2D | MTD of BGM-2121 in subjects with advanced solid tumors, used to determine the recommended Phase 2 dose (RP2D). | From first dose through the DLT evaluation period (28 days) |
| Incidence of Anti-Drug Antibodies (ADAs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Queena Hwang | Contact | 886-2-2517-6512 | 8556 | clinical@biogate.com.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Not yet recruiting | Tainan | Taiwan |
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Percentage of subjects who develop treatment-emergent ADAs during the study. |
| From first dose through 6 weeks after the last dose of study treatment |
| Peak Serum Concentration (Cmax) of BGM-2121 | Cmax derived from serum concentration data. | From first dose through 30 days after the last dose |
| Area under Curve (AUC) of BGM-2121 | AUC derived from serum concentration data. | From first dose through 30 days after the last dose |
| Objective Response Rate (ORR) | Percentage of subjects with complete or partial response according to RECIST 1.1 criteria. | From baseline through study completion, an average of 1 year |
| Progression-Free Survival (PFS) | Time from first treatment to documented disease progression or death. | From first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 80 weeks |
| National Taiwan University Hospital | Not yet recruiting | Taipei | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan |
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