Drug: BAT8010, Dosage: 2.1mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT8010, Dosage: 2.4mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT8010, Dosage: 2.7 mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT1006, Dosage: 15 mg/kg, Frequency: once every 3 weeks, Duration: 1year

BAT8010 for Injection

BAT1006 for Injection

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.

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

Number of participants with abnormal vital signs

Number of participants with abnormal physical examination

Number of cases with all adverse medical events that occur after the subject receives the investigational drug

Number of participants with abnormal Clinical laboratory tests

DoR is defined as the time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD) , reflecting the duration of ORR

The proportion of patients with tumor reduction or stability maintained for a certain period, including cases of complete response (CR), partial response (PR), and stable disease (SD)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT06376136	Advanced Solid ...	BAT8010 for Inj... BAT1006 for Inj...	18 Years -	Bio-Thera Solutions
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	NCT06376136	Advanced Solid ...	BAT8010 for Inj... BAT1006 for Inj...	18 Years -	Bio-Thera Solutions

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