Recruiting NCT06560112
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK104, AK112, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Recurrent Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Detailed description
This is a Phase 2, open label, multicohort, multicenter study designed to evaluate the efficacy and safety of combination therapy of AK104, AK112 and chemotherapy in recurrent ovarian cancer.
AK104 is a bispecific monoclonal antibody targeting both CTLA-4 and PD-1. AK112 is a bispecific monoclonal antibody targeting VEGF and PD-1.
Interventions
- Drug AK104
ivgtt - Drug AK112
ivgtt - Drug Chemotherapy
ivgtt
Primary outcome measures
- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator [Time frame: Up to 2 years]
Secondary outcome measures (5)
- progression-free survival (PFS) assessed by investigator per RECIST v1.1 [Time frame: Up to 2 years]
- duration of Response (DOR) assessed by investigator per RECIST v1.1 [Time frame: Up to 2 years]
- Time to Response (TTR) assessed by investigator per RECIST v1.1 [Time frame: Up to 2 years]
- Overall Survival(OS) [Time frame: Up to 2 years]
- Number of participants with adverse event (AE) [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- Signs the written informed consent form.
- Female participants who are at least 18 years of age on the day of signing informed consent with.
- ECOG of 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically diagnosed high-grade epithelial ovarian cancer (including high-grade serous, clear cell, G3 endometrioid) that has relapsed after platinum-containing standard chemotherapy.
- Recurrence of Platinum-sensitive (relapse ≥6 months after the end of platinum-containing therapy) who is not suitable for platinum-containing therapy after ≥ 3 lines of therapy;
- Recurrence of platinum resistance , ≤3 previous lines of therapy. Note: Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified.
- Has measurable disease based on RECIST v1.1 as determined by the site study team.
- Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.
- Has adequate organ function.
- All subjects of reproductive potential must agree to use an effective method of contraception, during and for 6 months after the last dose of study treatment.
Exclusion criteria
- Other pathological types such as mucinous cancer, low-grade serous carcinoma, carcinosarcoma, sex cord stromal cell tumor, etc.
- Presence of central nervous system (CNS) metastases or carcinomatous meningitis.
- Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.
- Patients with other active malignancies within 3 years prior to randomization.
- Received systemic anti-tumor therapy within 3 weeks prior to randomization.
- Any prior treatments targeting the mechanism of tumor immunity.
- Major surgical treatment, open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.
- Active or potentially recurrent autoimmune disease.
- Subjects who require systemic treatment with glucocorticoid (> 10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to randomization.
- Use of live vaccines within 4 weeks prior to randomization.
- Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Known history of interstitial lung disease or non-infectious pneumonitis.
- Serious infections requiring hospitalization.
- Presence of active infection requiring systemic therapy.
- Subjects with active hepatitis B and active viral hepatitis C.
- Active or documented inflammatory bowel diseases, active diverticulitis.
- Patients with clinically significant cardio-cerebrovascular disease.
- Unresolved toxicities from prior anticancer therapy.
- History of severe hypersensitivity reactions to other mAbs.
- Pregnant or lactating women.
- Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
- Exclusion Criteria for Chemotherapy-Related Cohorts (Cohorts 1,2,4): Known contraindications or allergy to PLD, paclitaxel or topotecan.
- Exclusion Criteria for AK112-Related Cohorts (Cohorts 2,3,4): Known contraindications or allergy to any component of VEGF mABs or any medical conditions that affect the safety of AK112.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06560112 · AK104-221