NCT05217693

A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid Tumors

A Phase I First-in-human, Open Label, Multicenter, Dose Escalation and Cohort Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1705 in Patients With Locally Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The study consists of two phases: dose-escalation (Phase I) and cohort expansion (Phase II).

Detailed description

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BB-1705	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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-06-01
• Completion: 2025-12-31
• First posted: 2022-02-01
• Last updated: 2025-07-24

Locations

7 sites across 1 country: China