Actively Recruiting
Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer
Led by Akeso · Updated on 2025-04-16
150
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An Exploratory, Multi-cohort Phase II Study of combination therapy of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer(PSOC)
CONDITIONS
Official Title
Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent form
- Female participants aged 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically confirmed epithelial, non-mucinous platinum-sensitive ovarian cancer (including ovarian, fallopian tube, and primary peritoneal cancers)
- Radiographic progression more than 6 months after last platinum-based chemotherapy
- BRCA-positive participants must have received prior poly adenosine phosphate-ribose polymerase inhibitor (PARPi) treatment
- Measurable disease based on RECIST 1.1 criteria
- Ability to provide formalin-fixed, paraffin-embedded tumor tissue
- Adequate organ function
- Agreement to use effective contraception during treatment and for 6 months after last dose
You will not qualify if you...
- Mucinous cancer, sex cord stromal cell tumor, or other pathological types
- Central nervous system metastases or carcinomatous meningitis
- Uncontrollable pleural, pericardial, or peritoneal effusions requiring repeated drainage
- Other active malignancies within 3 years before randomization
- Systemic anti-tumor therapy within 2 weeks before randomization
- Prior treatments targeting tumor immunity mechanisms
- Major surgery, open biopsy, or significant trauma within 4 weeks before randomization
- Need for elective major surgery during study
- Active or recurrent autoimmune disease
- Systemic glucocorticoid or immunosuppressive treatment within 14 days before randomization
- Live vaccines within 4 weeks before randomization
- Known immunodeficiencies including HIV
- History of allogeneic organ or hematopoietic stem cell transplantation
- History of interstitial lung disease or non-infectious pneumonitis
- Serious infections requiring hospitalization
- Active infections requiring systemic therapy
- Active hepatitis B or C
- Active or documented inflammatory bowel disease or diverticulitis
- Significant cardio-cerebrovascular disease
- Unresolved toxicities from prior cancer therapy
- Severe hypersensitivity to monoclonal antibodies
- Pregnant or breastfeeding women
- Any condition posing risk with study drug per investigator
- Known allergy or contraindication to paclitaxel or carboplatin for cohort 1
- Known allergy or contraindication to olaparib for cohorts 1-10A, 1-20A, and 2
- Known allergy or contraindication to VEGF monoclonal antibodies or medical conditions affecting AK112 safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, China, 430000
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
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here