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Cadonilimab (AK104) Plus Chemotherapy in Patients With Recurrent or Advanced Endometrial Cancer

Primary Purpose

Endometrial Cancer, Endometrial Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cadonilimab
Carboplatin
Cisplatin
Paclitaxel
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial Cancer, Immune Checkpoint Inhibitors (ICIs), Anti-PD-1/CTLA4 bi-specific antibody, Antiangiogenic agents, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years. Patients must have had measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer. All patients were required to have histologic confirmation of the original primary tumor (submission of pathology report(s) is required). Patients with the following histologic types were eligible: endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma. The patient may have received: 1) no prior chemotherapy for treatment of endometrial cancer, or 2) prior adjuvant chemotherapy for treatment of endometrial cancer(e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]), or 3) prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy, or 4) prior hormonal therapy for treatment of endometrial cancer. These must be stopped at least three weeks before the first date of study treatment. Recurrent or advanced endometrial cancer that is not suitable for local treatment, and advanced endometrial cancer that cannot tolerate radiotherapy. Prior antiangiogenic therapy is permitted. Recovering from the effects of recent radiation, surgery, or chemotherapy: if > 2 weeks before the study intervention, you may have previously received radiation with or without radiosensitizing chemotherapy. Participants had to recover from all radiation-related toxicity, no need to continue corticosteroid, and no radiation pneumonitis. For palliative radiotherapy for central nervous system (CNS) disease (≤2 weeks of radiotherapy) , washout was allowed for 1 week; Signed Informed Consent Form (ICF). In patients with measurable disease, lesions are defined and monitored by RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has adequate organ function as defined by the following criteria: 1) Blood routine examination standards to meet: (no blood transfusion within 14 days): Hemoglobin of ≥90 g/L, white blood cell (WBC) ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100 ×109/L 2) Biochemical examination should meet the following criteria: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (however, patients with known liver metastasis who have AST or ALT level ≤ 5 × ULN may be enrolled) Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula) TSH within normal limits. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal Free T3、Free T4 level are required. Plasma cortisol≤ 1 × ULN 3) Urine protein ≤(+) , or 24-hour urine protein quantification less than 1 g; 4) International standard ratio (INR) and activated partial thromboplastin time ≤1.5 uln (unless anticoagulant therapy is used because of disease) ; 12. Adverse events from any previous treatment, except for symptomatic stable sensory neuropathy or alopecia ≤ CTCAE Grade 2, have returned to ≤ CTCAE grade 1 or baseline, except anemia; 13. Women of childbearing potential should have a negative serum or urine pregnancy test prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices [IUDs]) throughout the period of taking study treatment and for at least 3 months after the last dose of study drug(s). 14. Life expectancy exceeds 3 months. Exclusion Criteria: Known history of other malignancy (in the last 5 years) except localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, breast carcinoma in situ that has undergone curative therapy and breast carcinoma that has not recurred for > 3 years after radical surgery Had received immunotherapy in the past, it includes immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.) , immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibody, etc.) , immune cell therapy, etc. Such subjects may be admitted with the consent of the sponsor. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Previous history of immunodeficiency; HIV antibody positive; Current long-term use of systemic corticosteroids or other immunosuppressants Subjects who are known to have active pulmonary tuberculosis (TB) and are suspected to have active TB need to undergo clinical examination to exclude them; Known active syphilis infection. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. Previous history of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid treatment or current presence of non-infectious pneumonia. Serious infections occur within 4 weeks before the first administration, including but not limited to comorbidities, sepsis, or severe pneumonia that require hospitalization; Active infections (excluding antiviral treatment for hepatitis B or C) that have received systemic anti-infective treatment within two weeks prior to the first administration. Untreated subjects with active hepatitis B (HBSAg positive and HBV-DNA above 1000 copies/ml (200 IU/ml) or above the lower limit of detection, whichever is higher), for subjects with Hepatitis B, anti-HBV therapy was required during study treatment; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) . Those who had a major surgical procedure or major trauma within 30 days before the first dose, or who had a major surgical plan within 30 days after the first dose (at the investigator's discretion); Minor local procedures (excluding central venous catheterization via peripheral venipuncture and implantable venous accessport) were performed within 3 days before the first dose. Known presence of central nervous system metastases (stable state without surgery or radiation therapy), meningeal metastases, spinal cord metastases, or compression. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. There are currently uncontrolled comorbidities, including but not limited to symptomatic congestive heart failure (grade 2 and above according to the New York Heart Association functional classification), unstable angina, acute myocardial ischemia, poorly controlled arrhythmia, decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, Mental illness/social status that may limit subjects' compliance with research requirements or affect their ability to provide written informed consent. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure, or vascular disease requiring hospitalization (such as aortic aneurysm at risk of rupture), or other cardiac impairment (such as poorly controlled arrhythmias, myocardial ischemia) that may affect study drug safety evaluation within 12 months prior to first administration of study drug; A history of esophageal Gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, tumor-related gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding in the 6 months before the first dose; Any arterial thromboembolic event, NCI CTCAE version 5.0 Grade 3 or higher, venous thromboembolism, transient cerebral ischemia, cerebrovascular accident, Hypertensive crisis, or hypertensive encephalopathy, occurred within 6 months before the first dose; Acute exacerbation of chronic obstructive pulmonary disease within 1 month of first dose Previous history of abdominal fistula or gastrointestinal perforation associated with anti-VEGF therapy; the imaging results revealed the invasion of intestinal wall by neoplasm during screening. During screening, imaging or clinical findings of gastrointestinal obstruction, including incomplete obstruction. Previous history of severe bleeding or coagulation disorders; during screening, imaging showed that the neoplasm surrounded major blood vessels or had obvious necrosis and cavitation, and the investigators believed that participation in the study might increase risk of bleeding. Toxicities from previous antitumour therapy did not resolve, defined as toxicities that did not return to grade 0 or 1 of NCI CTCAE version 5.0, or levels specified in the inclusion/exclusion criteria; Except for alopecia and sequelae of neurotoxicity related to previous platinum therapy. For subjects who develop irreversible toxicity and are not expected to worsen after administration of the study drug (EG, hearing loss), it may be included in the study after consultation with the medical examiner. Long-term radiation-induced toxicity in subjects who, in the judgment of the investigators, can not recover may be included in the study after consultation with the medical examiner. Has received a live virus vaccine within 30 days prior to first administration of study drug or plan to be administered during the study period. Known allergy to any component of any investigational drug, known history of severe hypersensitivity to other monoclonal antibody. Known history of mental illness, substance abuse, alcohol, or drug abuse. Is pregnant, breastfeeding women. Any prior or current disease, treatment, or laboratory test abnormality that may confound the study endpoints, interfere with subjects' full participation in the study, or may not be in their best interest to participate in this study. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor like leukemia reactions (white blood cell count>20 × 109/L), symptoms of cachexia (known to have lost more than 10% of body weight in the 3 months before screening), etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cadonilimab+carboplatin/cisplatin+paclitaxel

    Arm Description

    Cadonilimab (10 mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+ carboplatin(AUC=4-5, d1, Q3W, 6-8cycles) or cisplatin(75 mg/m2, d1, Q3W, 6-8cycles), +Paclitaxel(175 mg/m2, d1, Q3W, 6-8cycles), every 3 weeks (21 days) is a treatment cycle

    Outcomes

    Primary Outcome Measures

    Response Rate (ORR)
    ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Secondary Outcome Measures

    Disease Control Rate (DCR)
    Proportion of patients whose best overall response is either CR, PR, or SD
    Duration of response (DOR)
    Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first
    Progression-free Survival (PFS)
    Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first
    Overall survival (OS)
    Time from the date of first study treatment administration to the date of death due to any cause
    Adverse event (AE)
    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    October 7, 2023
    Sponsor
    Fujian Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06066216
    Brief Title
    Cadonilimab (AK104) Plus Chemotherapy in Patients With Recurrent or Advanced Endometrial Cancer
    Official Title
    Efficacy and Safety of Cadonilimab (AK104) Plus Chemotherapy in the Treatment of Recurrent or Advanced Endometrial Cancer: a Multicenter, Prospective Phase II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2025 (Anticipated)
    Study Completion Date
    October 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is an open-label, multi-center Phase II study of cadonilimab (AK104) combined with chemotherapy in patients with recurrent or advanced endometrial cancer. The primary objective is to evaluate objective response rate of cadonilimab plus chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Cancer, Endometrial Adenocarcinoma
    Keywords
    Endometrial Cancer, Immune Checkpoint Inhibitors (ICIs), Anti-PD-1/CTLA4 bi-specific antibody, Antiangiogenic agents, Chemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cadonilimab+carboplatin/cisplatin+paclitaxel
    Arm Type
    Experimental
    Arm Description
    Cadonilimab (10 mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+ carboplatin(AUC=4-5, d1, Q3W, 6-8cycles) or cisplatin(75 mg/m2, d1, Q3W, 6-8cycles), +Paclitaxel(175 mg/m2, d1, Q3W, 6-8cycles), every 3 weeks (21 days) is a treatment cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Cadonilimab
    Other Intervention Name(s)
    AK104
    Intervention Description
    Injectable solution
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    Injectable solution
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Intervention Description
    Injectable solution
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Description
    Injectable solutionS
    Primary Outcome Measure Information:
    Title
    Response Rate (ORR)
    Description
    ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    Time Frame
    from the first drug administration up to two years
    Secondary Outcome Measure Information:
    Title
    Disease Control Rate (DCR)
    Description
    Proportion of patients whose best overall response is either CR, PR, or SD
    Time Frame
    from the first drug administration up to two years
    Title
    Duration of response (DOR)
    Description
    Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first
    Time Frame
    from the first drug administration up to two years
    Title
    Progression-free Survival (PFS)
    Description
    Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first
    Time Frame
    from the first drug administration up to two years
    Title
    Overall survival (OS)
    Description
    Time from the date of first study treatment administration to the date of death due to any cause
    Time Frame
    from the first drug administration up to two years
    Title
    Adverse event (AE)
    Description
    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results
    Time Frame
    From the subject signs the ICF to 90 days after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first
    Other Pre-specified Outcome Measures:
    Title
    Biomarkers associated with the response to cadonilimab plus chemotherapy
    Description
    Exploration of biomarkers that predict the efficacy of cadonilimab combined with chemotherapy
    Time Frame
    Samples taken prior to the first dose of drug to confirm the result of MSI-H/dMMR

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years. Patients must have had measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer. All patients were required to have histologic confirmation of the original primary tumor (submission of pathology report(s) is required). Patients with the following histologic types were eligible: endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma. The patient may have received: 1) no prior chemotherapy for treatment of endometrial cancer, or 2) prior adjuvant chemotherapy for treatment of endometrial cancer(e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]), or 3) prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy, or 4) prior hormonal therapy for treatment of endometrial cancer. These must be stopped at least three weeks before the first date of study treatment. Recurrent or advanced endometrial cancer that is not suitable for local treatment, and advanced endometrial cancer that cannot tolerate radiotherapy. Prior antiangiogenic therapy is permitted. Recovering from the effects of recent radiation, surgery, or chemotherapy: if > 2 weeks before the study intervention, you may have previously received radiation with or without radiosensitizing chemotherapy. Participants had to recover from all radiation-related toxicity, no need to continue corticosteroid, and no radiation pneumonitis. For palliative radiotherapy for central nervous system (CNS) disease (≤2 weeks of radiotherapy) , washout was allowed for 1 week; Signed Informed Consent Form (ICF). In patients with measurable disease, lesions are defined and monitored by RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has adequate organ function as defined by the following criteria: 1) Blood routine examination standards to meet: (no blood transfusion within 14 days): Hemoglobin of ≥90 g/L, white blood cell (WBC) ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100 ×109/L 2) Biochemical examination should meet the following criteria: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (however, patients with known liver metastasis who have AST or ALT level ≤ 5 × ULN may be enrolled) Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula) TSH within normal limits. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal Free T3、Free T4 level are required. Plasma cortisol≤ 1 × ULN 3) Urine protein ≤(+) , or 24-hour urine protein quantification less than 1 g; 4) International standard ratio (INR) and activated partial thromboplastin time ≤1.5 uln (unless anticoagulant therapy is used because of disease) ; 12. Adverse events from any previous treatment, except for symptomatic stable sensory neuropathy or alopecia ≤ CTCAE Grade 2, have returned to ≤ CTCAE grade 1 or baseline, except anemia; 13. Women of childbearing potential should have a negative serum or urine pregnancy test prior to receiving the first dose of study treatment; and should be willing to use one acceptable contraception (i.e., oral contraceptives, condoms, intrauterine devices [IUDs]) throughout the period of taking study treatment and for at least 3 months after the last dose of study drug(s). 14. Life expectancy exceeds 3 months. Exclusion Criteria: Known history of other malignancy (in the last 5 years) except localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, breast carcinoma in situ that has undergone curative therapy and breast carcinoma that has not recurred for > 3 years after radical surgery Had received immunotherapy in the past, it includes immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.) , immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibody, etc.) , immune cell therapy, etc. Such subjects may be admitted with the consent of the sponsor. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Previous history of immunodeficiency; HIV antibody positive; Current long-term use of systemic corticosteroids or other immunosuppressants Subjects who are known to have active pulmonary tuberculosis (TB) and are suspected to have active TB need to undergo clinical examination to exclude them; Known active syphilis infection. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. Previous history of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid treatment or current presence of non-infectious pneumonia. Serious infections occur within 4 weeks before the first administration, including but not limited to comorbidities, sepsis, or severe pneumonia that require hospitalization; Active infections (excluding antiviral treatment for hepatitis B or C) that have received systemic anti-infective treatment within two weeks prior to the first administration. Untreated subjects with active hepatitis B (HBSAg positive and HBV-DNA above 1000 copies/ml (200 IU/ml) or above the lower limit of detection, whichever is higher), for subjects with Hepatitis B, anti-HBV therapy was required during study treatment; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) . Those who had a major surgical procedure or major trauma within 30 days before the first dose, or who had a major surgical plan within 30 days after the first dose (at the investigator's discretion); Minor local procedures (excluding central venous catheterization via peripheral venipuncture and implantable venous accessport) were performed within 3 days before the first dose. Known presence of central nervous system metastases (stable state without surgery or radiation therapy), meningeal metastases, spinal cord metastases, or compression. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. There are currently uncontrolled comorbidities, including but not limited to symptomatic congestive heart failure (grade 2 and above according to the New York Heart Association functional classification), unstable angina, acute myocardial ischemia, poorly controlled arrhythmia, decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, Mental illness/social status that may limit subjects' compliance with research requirements or affect their ability to provide written informed consent. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure, or vascular disease requiring hospitalization (such as aortic aneurysm at risk of rupture), or other cardiac impairment (such as poorly controlled arrhythmias, myocardial ischemia) that may affect study drug safety evaluation within 12 months prior to first administration of study drug; A history of esophageal Gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, tumor-related gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding in the 6 months before the first dose; Any arterial thromboembolic event, NCI CTCAE version 5.0 Grade 3 or higher, venous thromboembolism, transient cerebral ischemia, cerebrovascular accident, Hypertensive crisis, or hypertensive encephalopathy, occurred within 6 months before the first dose; Acute exacerbation of chronic obstructive pulmonary disease within 1 month of first dose Previous history of abdominal fistula or gastrointestinal perforation associated with anti-VEGF therapy; the imaging results revealed the invasion of intestinal wall by neoplasm during screening. During screening, imaging or clinical findings of gastrointestinal obstruction, including incomplete obstruction. Previous history of severe bleeding or coagulation disorders; during screening, imaging showed that the neoplasm surrounded major blood vessels or had obvious necrosis and cavitation, and the investigators believed that participation in the study might increase risk of bleeding. Toxicities from previous antitumour therapy did not resolve, defined as toxicities that did not return to grade 0 or 1 of NCI CTCAE version 5.0, or levels specified in the inclusion/exclusion criteria; Except for alopecia and sequelae of neurotoxicity related to previous platinum therapy. For subjects who develop irreversible toxicity and are not expected to worsen after administration of the study drug (EG, hearing loss), it may be included in the study after consultation with the medical examiner. Long-term radiation-induced toxicity in subjects who, in the judgment of the investigators, can not recover may be included in the study after consultation with the medical examiner. Has received a live virus vaccine within 30 days prior to first administration of study drug or plan to be administered during the study period. Known allergy to any component of any investigational drug, known history of severe hypersensitivity to other monoclonal antibody. Known history of mental illness, substance abuse, alcohol, or drug abuse. Is pregnant, breastfeeding women. Any prior or current disease, treatment, or laboratory test abnormality that may confound the study endpoints, interfere with subjects' full participation in the study, or may not be in their best interest to participate in this study. Local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor like leukemia reactions (white blood cell count>20 × 109/L), symptoms of cachexia (known to have lost more than 10% of body weight in the 3 months before screening), etc.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yang sun, doctor
    Phone
    +8615959028989
    Email
    sunyang@fjzlhospital.com

    12. IPD Sharing Statement

    Learn more about this trial

    Cadonilimab (AK104) Plus Chemotherapy in Patients With Recurrent or Advanced Endometrial Cancer

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