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 - Trial NCT06376136

Timeline & Enrollment

Primary Outcome

Dose-limiting toxicity (DLT),vital signs,Physical examination,Adverse events,Clinical laboratory tests,Number of participants with abnormal clinical auxiliary tests,Duration of Response(DOR),Disease Control Rate (DCR)

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.

ICD-10 Classifications