NCT07715747 A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
| NCT ID | NCT07715747 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | TJ Biopharma Co., Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2026-08-05 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 128 participants in total. It began in 2026-08-05 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07715747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07715747 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07715747 currently recruiting?
Yes, NCT07715747 is actively recruiting participants. Contact the research team at lina.qin@tjbio.com for enrollment information.
Where is the NCT07715747 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07715747 clinical trial?
NCT07715747 is sponsored by TJ Biopharma Co., Ltd.. The trial plans to enroll 128 participants.