NCT06241898

A First-in-human of Multiplle Doses of BB-1709 in Subjects With Locally Advanced/Metastatic Solid Tumors

A Phase I, Open Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of BB-1709 in Patients With Locally Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Bliss Biopharmaceutical (Hangzhou) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test in patients with local advanced/metastatic solid tumors. the main questions it aims to answer are: * to assess the safety and tolerability of BB-1709. * to determine the maximum tolerated dose(MTD) and/or the PR2D of BB-1709

Detailed description

The study consists of two parts: dose-escalation (Phase Ia) and dose expansion (Phase Ib). Phase Ia is a multicenter, open-label, first time in human clinical trial to assess safety, tolerability, pharmacokinetics, immunogenicity, the preliminary anti-tumor activity of BB-1709, and to establish the MTD and/or RP2D of BB-1709 in patients with advanced solid tumors. Phase Ib is to explore one or more RP2Ds to further assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of BB-1709 in patients with specific types of solid tumor.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BB-1709	Subjects participating in Phase Ia study may continue to receive study treatment as long as they continue to show clinical benefit as judged by the investigator, until disease progression or intolerable toxicity, withdrawal of consent, death, or termination of the study.

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2024-02-05
• Last updated: 2025-09-26

Locations

1 site across 1 country: China