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The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II).
Phase Ia is a dose escalation study to assess the safety and tolerability, and to determine the MTD or MAD and RP2D of BB-1705.
Phase Ib is a cohort expansion study to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. Patients with locally advanced and unresectable or metastatic solid tumors who have progressed on prior lines of standard of care therapies will be enrolled in this study if eligible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose escalation | Experimental | Drug: BB-1705 BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles |
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| cohort expansion | Experimental | BB-1705 will be administered as an intravenous infusion by Q3W for 8cycles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BB-1705 | Drug | BB-1705 is an ADC consisting of an engineered humanized IgG1κ monoclonal antibody conjugated to the cytotoxic agent eribulin via a cathepsin-cleavable valine-citrulline linker. BB-1705 has a molecular weight of approximately 152 kDa, including two molecules of eribulin via the linker. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and serious adverse events | To evaluate the safety and tolerability of BB-1705 | up to 2 years |
| Number of subjects with dose limiting toxicity (DLT) | Subjects are evaluated for all study drug related and treatment emergent toxicities based on the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE) | Cycle 1. Duration of each cycle is 21 days. |
| MTD | MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycle. | Cycle 1. Duration of each cycle is 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf) | To characterize the PK of BB-1705 | Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days. |
| Maximum observed plasma concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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To characterize the PK of BB-1705 |
| Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days. |
| Incidence of anti-drug antibodies | To assess the immunogenicity of BB-1705 | Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 4, 6, and 8. Duration of each cycle is 21 days. |
| Objective response | To assess the preliminary anti-tumor activity of BB-1705 | Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years) |
| Progression Free Survival | To assess the preliminary anti-tumor activity of BB-1705 | Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years) |
| Duration of Response | To assess the preliminary anti-tumor activity of BB-1705 | Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years) |
| Hunan Cancer Hospital | Recruiting | Changsha | China |
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| First affiliated hospital of Gannan medical university | Recruiting | Ganzhou | China |
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| Bliss Biopharmaceutical Co, Ltd | Recruiting | Hangzhou | China |
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| Zhejiang University School of Medicine - The First Affiliated Hospital | Recruiting | Hanzhou | China |
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| Linyi Cancer Hospital | Recruiting | Linyi | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | China |
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