A Phase I Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors

Official title

Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors

Overview

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

• Drug TJ037130
  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.

Primary outcome measures

• Incidence,type,severity and correlation with study treament of AEs [Time frame: Up to 90 days post last dose]

Secondary outcome measures (2)

• Pharmacokinetic (PK) Parameters: AUCt [Time frame: Up to 90 days post last dose]
• Pharmacokinetic (PK) Parameters: Cmax [Time frame: Up to 90 days post last dose]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai GoBroad Cancer Hospital — Shanghai

Identifiers

NCT: NCT07715747 · TJ037130STM101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗