NCT06376136

A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors

An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	BAT8010 for Injection	Intravenous
DRUG	BAT1006 for Injection	Intravenous

Timeline

• Start date: 2024-05-08
• Primary completion: 2026-11-09
• Completion: 2026-12-09
• First posted: 2024-04-19
• Last updated: 2025-08-13

Locations

1 site across 1 country: China