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.
age ≥18 years old, male and female, voluntarily sign informed consent;
Estimated survival ≥3 months as assessed by the investigators;
the Eastern UnitedStates Cancer Consortium (ECOG) physicalstatu sscore requirements of 0 to 1 points;
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.
During previous treatment with HER2-targeted drugs such as trastuzumab or pertuzumab, T-DM1, vedicitumab or Enhertu, as well as topoisomerase I inhibitors (such as irinotecan), grade 3 aes (including but not limited to infusion reactions or allergic reactions) that were determined to be treaty-related or of unknown drug relationship, or L after treatment VEF < 50%;
Participants who had previously received doxorubicin with cumulative dose > 360 mg/m2 or equivalent anthracyclines;
Before the first administration of the investigational drug, AE (CTCAE5.0) caused by previous antitumor therapy still had grade 1, except for the following cases: a. Hair loss; b Pigmentation; c. Patients with distal toxicity caused by chemotherapy and radiotherapy who can not be further recovered by judgment;
primary central nervous system tumor or symptomatic central nervous system metastasis, meningeal metastasis or a history of epilepsy. Patients with asymptomatic or asymptomatic central nervous system metastases under clinical control or who have symptoms but are judged to be stable by the investigators can be included, provided that the following conditions are met :a. The clinical symptoms were stable ≥4 weeks before the first dose. b. Brain MRI enhancement showed no evidence of progression of central nervous system disease within 4 weeks prior to initial administration; c. Antiepileptic drugs, hormones and other drugs have been stopped ≥2 weeks before the first administration;
Sequential
BAT8010 for Injection
DrugIntravenous
BAT1006 for Injection
DrugIntravenous
Dose-limiting toxicity (DLT)
DLT events and their incidence.
vital signs
Number of participants with abnormal vital signs
Physical examination
Number of participants with abnormal physical examination
Adverse events
Number of cases with all adverse medical events that occur after the subject receives the investigational drug
Pharmacokinetic
Level of Cmax
Pharmacokinetic
Level of Tmax
Pharmacokinetic
Level of CL
Pharmacokinetic
Level of T1/2
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