Targeting CLDN6-positive solid tumors with TJ037130

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study evaluates safety, pharmacokinetics, pharmacodynamics, and potential efficacy of TJ037130 in adults with advanced or metastatic solid tumors, including ovarian, gastric, and endometrial cancers. The trial aims to identify a potential optimal biological dose to guide future studies. Eligible participants have good performance status, measurable disease, and CLDN6 expression, and may provide tumor tissue samples. The study is conducted at Shanghai GoBroad Cancer Hospital and is led by TJ Biopharma Co., Ltd. Success in this trial could inform dose selection for subsequent trials and guide development of TJ037130 in CLDN6-expressing cancers.

Why it matters

Who can join: the full rules

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;

Where it's running

• Shanghai GoBroad Cancer Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lina Qin
• Email: lina.qin@tjbio.com
• Phone: +86-18600672907

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.