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| Name | Class |
|---|---|
| Emerald Clinical Inc. | INDUSTRY |
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This is a prospective multi-centre, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients with Advanced Solid Tumours in Australia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose 0.3mg/kg |
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| Cohort 2 | Experimental | Dose 1mg/kg |
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| Cohort 3 | Experimental | Dose: 3 mg/kg |
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| Cohort 4 | Experimental | Dose: 10 mg/kg |
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| Cohort 5 | Experimental | Dose: 20 mg/kg |
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| Cohort 6 | Experimental | Dose: 40 mg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT7104 | Biological | Symmetric IgG-like AntiPD-L1/CD47 Bispecific Antibody Solution for Injection BAT7104 injection available in 100 mg/2 mL (50 mg/mL) dosage |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Number of subjects who experience DLT events during 28 days. Toxicity will be graded according to CTCAE, Version 5.0. | A minimum of 28 days after first dose of BAT-7104 |
| Adverse Events (AEs) | Incidence of treatment -related AEs as assessed by CTCAE, Version 5.0. | up to 90 days after the last dose, an average of 1 year |
| Serious adverse events (SAEs) | Any SAE that is judged by the PI or designee to be related to the study medication must be reported regardless of the amount of time since the last dose received. Follow-up information collected for any initial report of an SAE must also be reported to the Sponsor (or its designee) within 24 hours of receipt by the PI or designee. | From the time of informed consent to 90 days after the last dose, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum serum concentration) | Maximum observed plasma or serum concentration | up to Cycle 6, each cycle is 14 days |
| Presence of anti-drug antibodies (ADAs) / neutralizing antibodies (NAbs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University | Sydney | New South Wales | 2109 | Australia | ||
| One Clinical Research Pty Ltd |
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| up to Cycle 6, each cycle is 14 days |
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | 12 months (anticipated) |
| Tmax (Time to reach maximum serum concentration) | Time to Maximum concentration | up to Cycle 6, each cycle is 14 days |
| AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration | area under the serum concentration versus time curve from time zero to infinity and to time λ | up to Cycle 6, each cycle is 14 days |
| Systemic Clearance (CL) | Systemic dose clearance | up to Cycle 6, each cycle is 14 days |
| Vss (volume of distribution at steady state) | Amount of drug in the body divided by plasma concentration | up to Cycle 6, each cycle is 14 days |
| t1/2 (terminal half-life) | Apparent terminal-phase disposition half-life. | up to Cycle 6, each cycle is 14 days |
| Nedlands |
| Australia |