Solid TumorPhase 1NCT07715747
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
A Phase 1 study testing TJ037130 in people with Solid Tumor and Metastatic Ovary Cancer, run by TJ Biopharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Ovary Cancer, Metastatic Gastric Cancer
- What is being tested?
- TJ037130
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2026to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai GoBroad Cancer Hospital
Shanghai, Shanghai Municipality
Jin Li, Docotor
About this study
Official title: Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
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.
- Conditions
- Solid Tumor, Metastatic Ovary Cancer, Metastatic Gastric Cancer, Metastatic Endometrial Carcinoma
- Being tested
- TJ037130
- Medical subject headings
- Ovarian Neoplasms, Stomach Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ037130Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| TJ037130 | Experimental | Not described Receives: Drug: TJ037130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence,type,severity and correlation with study treament of AEs
Measured: Up to 90 days post last dose
Secondary outcomes (2)
Pharmacokinetic (PK) Parameters: AUCt
Measured: Up to 90 days post last dose
Pharmacokinetic (PK) Parameters: Cmax
Measured: Up to 90 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start5 Aug 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TJ Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715747
- Sponsor's protocol ID
- TJ037130STM101
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07715747
- Acronym / sponsor ID
- TJ037130STM101
- Conditions
- Solid Tumor, Metastatic Ovary Cancer, Metastatic Gastric Cancer, Metastatic Endometrial Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJ037130 | Experimental | Drug: TJ037130 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ037130Dose 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. | Drug | TJ037130 |
Primary outcome
Incidence,type,severity and correlation with study treament of AEs
Time frame: Up to 90 days post last dose
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TJ037130 in people with Solid Tumor and Metastatic Ovary Cancer, run by TJ Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Qin (+86-18600672907, lina.qin@tjbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence,type,severity and correlation with study treament of AEs (time frame: Up to 90 days post last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.