Trial Title:
BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer
NCT ID:
NCT06321068
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Carboplatin
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
carboplatin
Description:
the usage and dosage should be determined by the investigator
Arm group label:
BAT1308
Other name:
Bobei
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
the usage and dosage should be determined by the investigator
Arm group label:
BAT1308
Other name:
Tesu
Intervention type:
Drug
Intervention name:
Recombinant humanized anti-PD-1 monoclonal antibody injection
Description:
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3
weeks (21 days) (Q3W).
Arm group label:
BAT1308
Other name:
BAT1308 injection
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
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years old and ≤75 years old, female, voluntarily sign informed consent;
2. 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.),
3. There is little likelihood of cure with surgery/radiotherapy alone or in
combination, or surgery or radiotherapy cannot be tolerated;
4. 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;
5. 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;
6. Expected survival assessed by investigators ≥12 weeks;
7. The physical status score of the American Eastern Cancer Consortium (ECOG) is
required to be 0 ~1 points;
8. 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.
Exclusion Criteria:
1. Have endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal
sarcoma.
2. Pregnant and lactating women;
3. 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;
4. 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;
5. 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;
6. 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;
7. 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;
8. 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.
9. 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;
10. Any active infection that requires systematic anti-infective therapy occurs within
14 days prior to the first administration of the investigational drug;
11. 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;
12. 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;
13. 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;
14. There is clinically significant hydronephrosis, which cannot be relieved by
nephrostomy or ureteral stenting according to the investigators;
15. Subjects with uncontrolled pleural effusion, pericardial effusion, or abdominal
effusion requiring repeated drainage;
16. 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);
17. 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);
18. Subjects with a history of noninfectious pneumonia requiring glucocorticoid therapy
or current interstitial lung disease within 1 year prior to initial administration;
19. 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);
20. Uncontrolled/unstable thrombotic or hemorrhagic disease;
21. Patients with other active malignant tumors within 3 years prior to screening,
except locally curable tumor species and those who have been cured;
22. Imaging examination showed that there were clear manifestations of tumor invasion of
the thoracic great blood vessels
23. Subjects with a known history of psychotropic substance abuse or drug use that is
thought to affect compliance with this study;
24. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem
cell transplantation;
25. 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.).
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Cancer Hospital of Chongqing University
Address:
City:
Chongqing
Country:
China
Start date:
April 9, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Bio-Thera Solutions
Agency class:
Industry
Source:
Bio-Thera Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06321068