The goal of this clinical trial is to evaluate the safety and tolerability of TJ037130 in participants with advanced or metastatic solid tumors, and to determine the Potential Optimal Biological Dose (POBD) of TJ037130 for subsequent investigations.
Males or females aged 18 years or older;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Voluntarily enroll in the study and be able to comply with scheduled visits, treatment schedules, laboratory tests and other study procedures;
Participants with histologically and/or cytologically confirmed recurrent or metastatic advanced malignant tumors for whom no standard therapy with clinical benefit is available, or who are ineligible for existing standard treatment regimens. Claudin 6 (CLDN6) positive expression confirmed by immunohistochemistry (IHC) ;
Prior exposure to CLDN6-targeted therapy;
Prior exposure to 4-1BB agonists;
Received PD-1/PD-L1 therapy or other immune checkpoint inhibitors/agonists within 28 days prior to the first dose of study drug;
History of a second malignancy within the past 3 years, except cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma, or carcinoma in situ of the cervix;
Sequential
TJ037130
DrugDose Escalation:TJ037130 will be administered at up to 5 dose levels(0.75,2,5,10 and 18mg/kg) once 3 weeks(Q3W); During dose expansion, TJ037130 will be administered once 3 weeks in 4 Cohorts.
Incidence,type,severity and correlation with study treament of AEs
Pharmacokinetic (PK) Parameters: AUCt
Pharmacokinetic (PK) Parameters: Cmax
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This trial is not recruiting at the moment. You can still explore other options:
