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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
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.
Beijing Cancer Hospital
Beijing, China
RECRUITINGHunan Cancer Hospital
Changsha, China
RECRUITINGFirst affiliated hospital of Gannan medical university
Ganzhou, China
Number of subjects with adverse events and serious adverse events
To evaluate the safety and tolerability of BB-1705
Time frame: 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)
Time frame: 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.
Time frame: Cycle 1. Duration of each cycle is 21 days.
Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
To characterize the PK of BB-1705
Time frame: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.
Maximum observed plasma concentration (Cmax)
To characterize the PK of BB-1705
Time frame: 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
Time frame: 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
Time frame: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)
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Bliss Biopharmaceutical Co, Ltd
Hangzhou, China
RECRUITINGZhejiang University School of Medicine - The First Affiliated Hospital
Hanzhou, China
RECRUITINGLinyi Cancer Hospital
Linyi, China
RECRUITINGJiangsu Province Hospital
Nanjing, China
RECRUITINGProgression Free Survival
To assess the preliminary anti-tumor activity of BB-1705
Time frame: 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
Time frame: Every 6 weeks within 6 months and approximately every 9 weeks thereafter (up to 2 years)