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
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. age ≥18 years old, male and female, voluntarily sign informed consent; 2. Estimated survival ≥3 months as assessed by the investigators; 3. the Eastern UnitedStates Cancer Consortium (ECOG) physicalstatu sscore requirements of 0 to 1 points; 4. Included in the crowd: 1. Dose escalation stage: Patients with HER-2 expression confirmed by histopathology and cytopathology (including IHC3+, IHC2+/FISH+ and IHC2+/FISH-) who have failed standard therapy or have no standard treatment options or are not suitable for standard therapy at this stage, The climbing stage includes but is not limited to breast cancer, stomach cancer, non-small cell lung cancer, biliary tract cancer, colorectal cancer, urothelial carcinoma, etc. 2. Dose expansion phase: divided into 3 cohorts i. Cohort A: Patients with breast cancer with HER-2 expression (including IHC3+, IHC2+/FISH+ and IHC2+/FISH-) confirmed by histopathology and cytopathology after failure of standard treatment or no standard