Actively Recruiting
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Led by Akeso · Updated on 2025-03-12
172
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
CONDITIONS
Official Title
An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants at least 18 years old who sign informed consent
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically confirmed high-grade epithelial ovarian cancer (including high-grade serous, clear cell, or G3 endometrioid) that has relapsed after platinum-containing chemotherapy
- Recurrence either platinum-sensitive (relapse 6 months or more after therapy) with at least 3 prior therapies and not suitable for further platinum therapy, or platinum-resistant with 3 or fewer prior therapies
- Measurable disease based on RECIST v1.1 criteria
- Ability to provide formalin-fixed, paraffin-embedded tumor tissue
- Adequate organ function
- Agreement to use effective contraception during and for 6 months after treatment for those of reproductive potential
You will not qualify if you...
- Other pathological ovarian cancer types such as mucinous cancer, low-grade serous carcinoma, carcinosarcoma, or sex cord stromal tumors
- Presence of central nervous system metastases or carcinomatous meningitis
- Uncontrollable pleural, pericardial, or peritoneal effusion needing repeated drainage
- Other active cancers within 3 years before study
- Systemic anti-tumor therapy received within 3 weeks before study
- Prior treatments targeting tumor immunity mechanisms
- Major surgery, open biopsy, or significant trauma within 4 weeks before study or planned major surgery during study
- Active or potentially recurring autoimmune diseases
- Need for systemic glucocorticoids (>10 mg prednisone or equivalent) or immunosuppressants within 14 days before study
- Use of live vaccines within 4 weeks before study
- Known immunodeficiency including HIV infection
- History of allogeneic organ or stem cell transplantation
- History of interstitial lung disease or non-infectious pneumonitis
- Serious infections requiring hospitalization
- Active infections needing systemic therapy
- Active hepatitis B or C
- Active or documented inflammatory bowel disease or diverticulitis
- Clinically significant cardio-cerebrovascular disease
- Unresolved toxicities from prior cancer therapy
- History of severe allergic reactions to monoclonal antibodies
- Pregnant or breastfeeding women
- Conditions posing risk with study drugs as judged by investigator
- Known allergies or contraindications to PLD, paclitaxel, or topotecan (for chemotherapy cohorts)
- Known allergies or contraindications to VEGF monoclonal antibodies or conditions affecting safety of AK112 (for AK112 cohorts)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
T
Ting Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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