BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer

NCT06321068 | Terminated Phase 2

• 1 other identifier: BAT-1308-003-CR
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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) endometrial carcinoma

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (7)

• vital signs

  Number of participants with abnormal vital signs

  Through study completion, 1 year

• Physical examination

  Number of participants with abnormal physical examination

  Through study completion, 1 year

• Adverse events

  Number of participants with various adverse events (AEs)

  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

  Through study completion, 1 year

• Clinical auxiliary tests

  Number of participants with abnormal clinical auxiliary tests

  Through study completion, 1 year

• Dose-limiting toxicity (DLT)

  DLT events and their incidence

  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.

  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

  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

  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

  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

  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

  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).

Study Arms (1)

BAT1308

EXPERIMENTAL

Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)

Drug: carboplatin; Drug: Paclitaxel; Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection

Interventions

carboplatin DRUG

the usage and dosage should be determined by the investigator

Also known as: Bobei

BAT1308

Paclitaxel DRUG

the usage and dosage should be determined by the investigator

Also known as: Tesu

BAT1308

Recombinant humanized anti-PD-1 monoclonal antibody injection DRUG

Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).

Also known as: BAT1308 injection

BAT1308

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Affiliated Cancer Hospital of Chongqing University

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: March 20, 2024
• Study Start: April 9, 2024
• Primary Completion: May 30, 2025
• Study Completion: August 7, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-03

Locations

CN (1)