NCT06341114

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors

A Multicenter, Open-label Phase Ib-II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy. The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BAT8008 injection	BAT8008 for injection is a sterile, preservative-free lyophilized powder packaged in vials, with each vial containing 100 mg,Prior to infusion, reconstitute with 5 milliliters of sterile water for injection. After reconstitution, a clear to slightly opalescent, colorless to pale yellow solution with a final concentration of 20 mg/mL can be obtained.
DRUG	BAT1308 injection	One vial of 4 mL of concentrate contains 100 mg of BAT1308.

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-04-03
• Completion: 2026-07-28
• First posted: 2024-04-02
• Last updated: 2025-12-08

Locations

1 site across 1 country: China