Drug: BAT8010, Dosage: 0.8mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT8010, Dosage: 1.2mg/kg, Frequency: once every 3 weeks, Duration: 1year

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

Drug: BAT8010, Dosage: 3.6mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT8010, Dosage: 4.8mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT8010, Dosage: 6.0mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT8010, Dosage: 7.2mg/kg, Frequency: once every 3 weeks, Duration: 1year

Drug: BAT8010, Dosage: 8.4mg/kg, Frequency: once every 3 weeks, Duration: 1year

BAT8010 for Injection

Cuiyu Li

Shusen Wang

Chaohe Wang

The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT8010 for injection in patients with advanced or metastatic solid tumors, explore the maximum tolerable dose. Participants will be given one of below dose once every three weeks: 0.8mg/kg, 1.2mg/kg, 2.4mg/kg, 3.6mg/kg, 4.8mg/kg, 6.0mg/kg, 7.2mg/kg, 8.4mg/kg. The dose escalation follow adopt accelerated titration and "3+3" dose increasing rule.

Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients

A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BAT8010 for Injection in Patients With Advanced or Metastatic Solid Tumors

Grade 5 toxicity; Hematological toxicity: Grade 4 alanine-aminotransferase(ALT) or aspartate-aminotransferase(AST) increase: AST or ALT\>5 times upper limit of normal value(ULN), with ≥ 2 levels of blood bilirubin increase; Hematological toxicity: Grade 4 neutropenia lasting\>7 days. ≥Grade 3 neutropenia with fever (single body temperature\>38.3 or continuous body temperature ≥ 38 ℃, more than 1 Hour). Grade 4 anemia. Grade 4 thrombocytopenia. ≥ Grade 3 thrombocytopenia and lasting\>7 days. ≥ Grade 3 thrombocytopenia with bleeding; Other ≥Grade 3 non hepatic toxicity, non hematological toxicity.

MTD was defined as the highest dose level of DLT observed in ≤1/6 subjects in a dose group during the DLT evaluation period

Presence of anti drug antibody (ADA)/Neutralizing antibodies (NAb) ADA, Nab

Refers to the proportion of patients whose tumors have shrunk to a certain amount and remained for a certain period of time, including CR and PR cases. Specifically divided into: 1.The ratio of patients with partial response (PR) or complete remission (CR) efficacy at the end of the first 6 cycles (18 weeks) of treatment. 2.The proportion of patients whose best response reached PR or CR during the entire study period.

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 reduced or stable tumors that remain for a certain period of time, including CR, PR, and Disease stability (SD) cases.

The time from the first administration to the occurrence of objective tumor progression or all cause death

The time from the date of first administration to the occurrence of death due to any cause. Subjects who were still alive at the time of analysis will use the date of their last contact as the deadline.

Bio-Thera Solutions

Drug: BAT8010, Dosage: 2.1mg/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

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
Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients	NCT05848466	Advanced or Met...	BAT8010 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
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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