A Phase I Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130… (NCT07715747) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
China128 participantsStarted 2026-08-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence,type,severity and correlation with study treament of AEs