Endometrial CancerPhase 2/3NCT06321068
BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer
A Phase 2/3 study testing carboplatin, Paclitaxel and Recombinant humanized anti-PD-1 monoclonal antibody injection in people with Endometrial Cancer, run by Bio-Thera Solutions at 1 site in China.
Trial summary
Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR)… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- carboplatin, Paclitaxel and Recombinant humanized anti-PD-1 monoclonal antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2024to 7 Aug 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤75 years old, female, voluntarily sign informed consent;
- The patient must have one of the following types of endometrial cancer: a) Newly diagnosed stage III disease (lesions assessed as measurable according to RECIST 1.1 after surgery or diagnostic biopsy), b) newly diagnosed stage IV disease (small lesions assessed as measurable or unmeasurable according to RECIST 1.1 after surgery or diagnostic biopsy, and truly unmeasurable lesions need to be excluded, (such as ascites, pleural effusion, etc.) c) recurrent diseases (small foci assessed as measurable or unmeasurable according to RECIST 1.1, truly unmeasurable foci, such as ascites, pleural effusion, etc.),
- There is little likelihood of cure with surgery/radiotherapy alone or in combination, or surgery or radiotherapy cannot be tolerated;
- Have not received first-line systemic anticancer therapy. Prior chemotherapy is permissible only for patients with recurrent disease if it is received under adjuvant conditions (as part of prior/adjuvant anticancer therapy) and the interval between the last dose of chemotherapy and the date of subsequent recurrence is at least 6 months;
- Subjects should meet the requirements of mismatch repair protein deficiency (dMMR) detected by the central laboratory of tumor specimen. Subjects should provide sufficient paraffin embedded (FFPE) specimens or sections (6 recommended, no less than 3) and be willing to undergo tumor tissue biopsies if needed for MMR status detection. The archived tissue must be a representative tumor specimen less than three years old, or an unstained continuous section of newly cut FFPE tumor tissue within six months, and the relevant pathological report of the above specimen must be provided. Fresh tissue specimens can be harvested by surgical excision and biopsy. Do not accept fine needle puncture and liquid based cytology (TCT) samples (i.e., samples that lack complete tissue structure and only provide cell suspension and/or cell smear); Decalcified bone metastatic tumor tissue specimens are not accepted;
- Expected survival assessed by investigators ≥12 weeks;
- The physical status score of the American Eastern Cancer Consortium (ECOG) is required to be 0 ~1 points;
- Fertile female patients must have a negative serological pregnancy test within 7 days prior to the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.
Who cannot join
- Have endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma.
- Pregnant and lactating women;
- Radical radiation therapy was received within 3 months before the first administration of the study drug. Note: Palliative radiotherapy for bone or superficial lesions is permitted, the course of treatment is according to local standards and has ended 14 days before the first dose. Radiotherapy that covers more than 30% of the bone marrow area within 28 days prior to initial dosing is not permitted; Received chemotherapy drugs for radiosensitization within 14 days prior to initial administration; Within 14 days prior to the first administration of the drug, have received the NMPA-approved Chinese patent medicine or treatment clearly with anti-tumor related functions, or the medical record clearly recorded in the anti-tumor purpose of Chinese herbal therapy;
- are participating in the treatment stage of other clinical studies, or plan to start this study treatment less than 14 days from the end of drug treatment of the previous clinical study;
- Have received live/attenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live/attenuated vaccines and mrna vaccines during the study period;
- Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or immunocostimulatory factors (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) and other treatments targeting tumor immune mechanisms;
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- Before the first administration of antitumor therapy, there were still more than grade 1 aes (based on CTCAE v5.0) (except for alopecia, fatigue and other AE that could not be restored to grade 1 or less and would remain in a stable state for a long time as judged by researchers based on clinical conditions, and grade 2 peripheral neurotoxicity. Except for stable hypothyroidism after hormone replacement therapy); Those who had a history of ≥ grade 3 irAE or had discontinued immunotherapy for any grade of irAE;
- Active pia meningeal disease or poorly controlled brain metastases. Patients with suspected or confirmed BMS were admitted if they were asymptomatic, had stable disease on imaging findings ≥28 days prior to first administration of the study drug, and did not require treatment (such as radiation therapy, surgery, or corticosteroid therapy) to control symptoms of BMS for 28 days prior to first administration of the study drug.
- Patients who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first use of the study drug, or who required elective surgery during the trial period;
- Any active infection that requires systematic anti-infective therapy occurs within 14 days prior to the first administration of the investigational drug;
- there are the following diseases infected: human immunodeficiency virus (HIV) infection; Active hepatitis B virus infection [hepatitis B surface antigen (HBsAg) positive, HBV deoxyribonucleic acid (HBV-DNA) test >500IU/ml or 103 copies /ml or greater than the upper limit of normal test unit]; HCV infection [HCV antibody and viral ribonucleic acid (HCV-RNA) test positive or greater than the upper limit of the normal value of the test unit]; Treponema pallidum antibody positive and RPR positive;
- Subjects with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included;
- Known to have a history of severe allergy, or known subjects have had grade 3 or greater allergic reactions to macromolecular protein preparations/monoclonal antibodies or to any of the test drug components;
- There is clinically significant hydronephrosis, which cannot be relieved by nephrostomy or ureteral stenting according to the investigators;
- Subjects with uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring repeated drainage;
- Patients with active or prior autoimmune disease with a history of recurrence (excluding vitiligo, autoimmune thyroid disease that can be treated with hormone replacement therapy, type 1 diabetes);
- Received systemic use of glucocorticoids (prednisone > 10mg/ day or equivalent dose of the same drug) or other immunosuppressants within 14 days prior to the first use of the study drug, except for the following: Treatment with topical, ocular, intraarticular, intranasal and inhaled glucocorticoids, and short-term prophylactic treatment with glucocorticoids (for example, to prevent hypersensitivity to contrast media);
- Subjects with a history of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
- have a history of serious cardiovascular and cerebrovascular disease, including but not limited to: ① New York Heart Association (NYHA) grade II or above heart failure or left ventricular ejection fraction (LVEF) < 50%; (2) There are serious heart rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, degree Ⅱ-Ⅲ atrioventricular block, etc.; ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before the first dose; (4) Clinically uncontrollable hypertension (defined in this protocol as systolic blood pressure > 160mmHg and/or diastolic blood pressure > 100mmHg despite antihypertensive therapy);
- Uncontrolled/unstable thrombotic or hemorrhagic disease;
- Patients with other active malignant tumors within 3 years prior to screening, except locally curable tumor species and those who have been cured;
- Imaging examination showed that there were clear manifestations of tumor invasion of the thoracic great blood vessels
- Subjects with a known history of psychotropic substance abuse or drug use that is thought to affect compliance with this study;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Subjects deemed unsuitable for participation in this study (considerations include but are not limited to: impact on compliance, safety and ethical considerations, impact on interpretation of study results, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality
About this study
Official title: Phase II/III Study of the Safety and Efficacy of BAT1308 in Combination With Platinum-containing Chemotherapy for First-line Treatment of Advanced or Recurrent Mismatch Repair Protein-deficient (dMMR) Endometrial Cancer
Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma
Read the detailed description
Phase II is a single-arm safety and efficacy study to explore the safety and initial efficacy of BAT1308 combined with platinum-containing chemotherapy. The first 6 patients (using 3+3 method) were included in the safe induction period, and 3 subjects were included first DLT assessment was performed. If there were less than 2 cases of DLT, 3 subjects were further included for DLT assessment Less than 2 cases of DLT in the total 6 cases were formally entered into the phase II study, if the phase II combination drug regimen was safe Phase II enrollment was stopped and phase III study was entered when the full treatment was controllable and the efficacy was in line with expectations. Phase I study is BAT1308 in combination with platinum-containing chemotherapy vs. placebo plus platinum-containing chemotherapy for advanced first-line treatment or A randomized, double-blind, multicenter clinical study of patients with recurrent dMMR endometrial cancer. PFS As the primary endpoint, optimal design. Stratified by the following random factors Histological randomization: according to disease status (stage III, IV, or relapse), prior pelvic extrinsic release Patients were stratified by treatment history (yes or no).
- Conditions
- Endometrial Cancer
- Being tested
- carboplatin, Paclitaxel, Recombinant humanized anti-PD-1 monoclonal antibody injection
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
Also called Bobei
the usage and dosage should be determined by the investigator
PaclitaxelDrug
Also called Tesu
the usage and dosage should be determined by the investigator
Recombinant humanized anti-PD-1 monoclonal antibody injectionDrug
Also called BAT1308 injection
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| BAT1308 | Experimental | Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) Receives: Drug: carboplatin; Drug: Paclitaxel; Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital signs
Number of participants with abnormal vital signs
Measured: Through study completion, 1 year
Physical examination
Number of participants with abnormal physical examination
Measured: Through study completion, 1 year
Adverse events
Number of participants with various adverse events (AEs)
Measured: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy, whichever occurs earlier，assessed up to 1 year
Clinical laboratory tests
Number of participants with abnormal clinical laboratory tests
Measured: Through study completion, 1 year
Clinical auxiliary tests
Number of participants with abnormal clinical auxiliary tests
Measured: Through study completion, 1 year
Dose-limiting toxicity (DLT)
DLT events and their incidence
Measured: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy，assessed up to 1 year
Progression Free Survival
Progression Free Survival（PFS ）in patients with advanced or recurrent dMMR endometrial cancer treated with BAT1308 combined with platinum-containing chemotherapy were compared with platinum-containing chemotherapy in first-line treatment by IRC according to RECIST V1.1.
Measured: Tumor imaging assessments will be performed once every 6 (±7) days during the screening period, once every 6 (±7) days after initial dosing to 25 weeks, and once every 9 (±7) weeks，assessed up to 1 year，the screening period is 28 days
Secondary outcomes (7)
Initial efficacy
Initial efficacy was assessed by investigators according to the solid tumor Efficacy Evaluation Criteria (RECIST V1.1)
Measured: Tumor imaging assessments will be performed once every 6 (±7) days during the screening period, once every 6 (±7) days after initial dosing to 25 weeks, and once every 9 (±7) weeks，assessed up to 1 year
Pharmacokinetic
Level of Cmax
Measured: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Level of Tmax
Measured: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Level of T1/2
Measured: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Level of CL
Measured: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Immunogenicity
Level of ADA
Measured: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days
Immunogenicity
Level of NAb
Measured: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start9 Apr 2024
- Primary completion30 May 2025
- Study completion7 Aug 2025
Why it stopped: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321068
- Sponsor's protocol ID
- BAT-1308-003-CR
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2024
- Last updated
- 14 Aug 2025
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Study of the Safety and Efficacy of BAT1308 in Combination With Platinum-containing Chemotherapy for First-line Treatment of Advanced or Recurrent Mismatch Repair Protein-deficient (dMMR) Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06321068
- Acronym / sponsor ID
- BAT-1308-003-CR
- Conditions
- Endometrial Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 20 Mar 2024 (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.
Phase II study: Safety and preliminary efficacy of BAT1308 combined with platinum-containing chemotherapy;Phase III study: Confirmatory safety and efficacy study of BAT1308 combined with platinum-containing chemotherapy for first-line treatment of advanced or recurrent mismatch repair protein-deficient (dMMR) endometrial carcinoma
Detailed description
Phase II is a single-arm safety and efficacy study to explore the safety and initial efficacy of BAT1308 combined with platinum-containing chemotherapy. The first 6 patients (using 3+3 method) were included in the safe induction period, and 3 subjects were included first DLT assessment was performed. If there were less than 2 cases of DLT, 3 subjects were further included for DLT assessment Less than 2 cases of DLT in the total 6 cases were formally entered into the phase II study, if the phase II combination drug regimen was safe Phase II enrollment was stopped and phase III study was entered when the full treatment was controllable and the efficacy was in line with expectations. Phase I study is BAT1308 in combination with platinum-containing chemotherapy vs. placebo plus platinum-containing chemotherapy for advanced first-line treatment or A randomized, double-blind, multicenter clinical study of patients with recurrent dMMR endometrial cancer. PFS As the primary endpoint, optimal design. Stratified by the following random factors Histological randomization: according to disease status (stage III, IV, or relapse), prior pelvic extrinsic release Patients were stratified by treatment history (yes or no).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT1308 | Experimental | Drug: carboplatin, Drug: Paclitaxel, Drug: Recombinant humanized anti-PD-1 monoclonal antibody injectionStrength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old and ≤75 years old, female, voluntarily sign informed consent;
- The patient must have one of the following types of endometrial cancer: a) Newly diagnosed stage III disease (lesions assessed as measurable according to RECIST 1.1 after surgery or diagnostic biopsy), b) newly diagnosed stage IV disease (small lesions assessed as measurable or unmeasurable according to RECIST 1.1 after surgery or diagnostic biopsy, and truly unmeasurable lesions need to be excluded, (such as ascites, pleural effusion, etc.) c) recurrent diseases (small foci assessed as measurable or unmeasurable according to RECIST 1.1, truly unmeasurable foci, such as ascites, pleural effusion, etc.),
- There is little likelihood of cure with surgery/radiotherapy alone or in combination, or surgery or radiotherapy cannot be tolerated;
- Have not received first-line systemic anticancer therapy. Prior chemotherapy is permissible only for patients with recurrent disease if it is received under adjuvant conditions (as part of prior/adjuvant anticancer therapy) and the interval between the last dose of chemotherapy and the date of subsequent recurrence is at least 6 months;
- Subjects should meet the requirements of mismatch repair protein deficiency (dMMR) detected by the central laboratory of tumor specimen. Subjects should provide sufficient paraffin embedded (FFPE) specimens or sections (6 recommended, no less than 3) and be willing to undergo tumor tissue biopsies if needed for MMR status detection. The archived tissue must be a representative tumor specimen less than three years old, or an unstained continuous section of newly cut FFPE tumor tissue within six months, and the relevant pathological report of the above specimen must be provided. Fresh tissue specimens can be harvested by surgical excision and biopsy. Do not accept fine needle puncture and liquid based cytology (TCT) samples (i.e., samples that lack complete tissue structure and only provide cell suspension and/or cell smear); Decalcified bone metastatic tumor tissue specimens are not accepted;
Key exclusion criteria (25 listed)
- Have endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma.
- Pregnant and lactating women;
- Radical radiation therapy was received within 3 months before the first administration of the study drug. Note: Palliative radiotherapy for bone or superficial lesions is permitted, the course of treatment is according to local standards and has ended 14 days before the first dose. Radiotherapy that covers more than 30% of the bone marrow area within 28 days prior to initial dosing is not permitted; Received chemotherapy drugs for radiosensitization within 14 days prior to initial administration; Within 14 days prior to the first administration of the drug, have received the NMPA-approved Chinese patent medicine or treatment clearly with anti-tumor related functions, or the medical record clearly recorded in the anti-tumor purpose of Chinese herbal therapy;
- are participating in the treatment stage of other clinical studies, or plan to start this study treatment less than 14 days from the end of drug treatment of the previous clinical study;
- Have received live/attenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live/attenuated vaccines and mrna vaccines during the study period;
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 |
|---|---|---|
| carboplatinAlso: Bobeithe usage and dosage should be determined by the investigator | Drug | BAT1308 |
| PaclitaxelAlso: Tesuthe usage and dosage should be determined by the investigator | Drug | BAT1308 |
| Recombinant humanized anti-PD-1 monoclonal antibody injectionAlso: BAT1308 injectionStrength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W). | Drug | BAT1308 |
Primary outcome
vital signs
Time frame: Through study completion, 1 year
Number of participants with abnormal vital signs
Physical examination
Time frame: Through study completion, 1 year
Number of participants with abnormal physical examination
Adverse events
Time frame: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy, whichever occurs earlier，assessed up to 1 year
Number of participants with various adverse events (AEs)
Clinical laboratory tests
Time frame: Through study completion, 1 year
Number of participants with abnormal clinical laboratory tests
Clinical auxiliary tests
Time frame: Through study completion, 1 year
Number of participants with abnormal clinical auxiliary tests
Dose-limiting toxicity (DLT)
Time frame: From the first receipt of the investigational drug until 28 (+7) days after the last receipt of the investigational drug or the initiation of a new antitumor therapy，assessed up to 1 year
DLT events and their incidence
Progression Free Survival
Time frame: Tumor imaging assessments will be performed once every 6 (±7) days during the screening period, once every 6 (±7) days after initial dosing to 25 weeks, and once every 9 (±7) weeks，assessed up to 1 year，the screening period is 28 days
Progression Free Survival（PFS ）in patients with advanced or recurrent dMMR endometrial cancer treated with BAT1308 combined with platinum-containing chemotherapy were compared with platinum-containing chemotherapy in first-line treatment by IRC according to RECIST V1.1.
7 secondary outcomes
Initial efficacy
Time frame: Tumor imaging assessments will be performed once every 6 (±7) days during the screening period, once every 6 (±7) days after initial dosing to 25 weeks, and once every 9 (±7) weeks，assessed up to 1 year
Pharmacokinetic
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Pharmacokinetic
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days(The first 12 subjects).
Immunogenicity
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days
Immunogenicity
Time frame: At the end of Cycel1Day1,cycle3Day1,Cycle5Day1,after Cycle5, for 9 weeks，assessed up to 1 year，each cycle is 28 days
Results and safety
The study was stopped early (reason given: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing carboplatin, Paclitaxel and Recombinant humanized anti-PD-1 monoclonal antibody injection in people with Endometrial Cancer, run by Bio-Thera Solutions 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 8 inclusion and 25 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: stopped early, as of the sponsor's last update on 14 Aug 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the adjustment of our company's research and development strategy, we are now prematurely terminating this project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital signs (time frame: Through study completion, 1 year). The study lists 7 primary outcomes in all. 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 14 Aug 2025.