Metastatic Endometrial Carcinoma, Metastatic Gastric Cancer, Metastatic Ovary Cancer, Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGTJ037130
Dose 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.
Sponsors
TJ Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) ; * Agree to provide archived tumor tissue or fresh biopsy tumor samples (not mandatory during the dose escalation phase); * Have at least one evaluable tumor lesion per RECIST Version 1.1 (dose escalation phase); have at least one measurable tumor lesion per RECIST Version 1.1 (dose expansion phase); * All acute adverse events resulting from prior anticancer therapies have resolved to Grade ≤ 1 or baseline per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (excluding toxicities judged by the Investigator to pose no safety risk, such as alopecia, peripheral neurotoxicity, hypothyroidism stabilized with hormone replacement therapy, etc.); * Be deemed an appropriate candidate for this clinical trial by the Investigator with an expected survival of ≥ 12 weeks; * Demonstrate adequate organ function within 7 days prior to the first dose of study drug; * Male and female participants of childbearing potential must agree to use two forms of effective contraception throughout the study period and for 6 months after the last dose of TJ037130. In addition, female participants of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion criteria
* 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence,type,severity and correlation with study treament of AEs | Up to 90 days post last dose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Parameters: AUCt | Up to 90 days post last dose |
| Pharmacokinetic (PK) Parameters: Cmax | Up to 90 days post last dose |
Countries
China
Contacts
CONTACTLina Qin
CONTACTLiting Liu
Outcome results
None listed