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An Exploratory, Multi-cohort Phase II Study of Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

An Exploratory, Multi-cohort Phase II Study of combination therapy of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer(PSOC)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 documented epithelial and non-mucinous PSOC. PSOC was defined as radiographic progression greater than 6 months from last dose of platinum-based chemotherapy.

• Note:

⁃ If breast cancer susceptibility gene (BRCA) positive participants must have received prior treatment with a poly adenosine phosphate-ribose polymerase inhibitor (PARPi).

⁃ Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified.

• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 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.

Locations
Other Locations
China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
RECRUITING
Wuhan
Contact Information
Primary
Ting Liu, M.D.
clinicaltrials@akesobio.com
(0760)89873999
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2028-07
Participants
Target number of participants: 150
Treatments
Experimental: Cohort 1-10 (BRCAm)
AK112(10mg/kg)+chemo for 4-6 cycles, AK112 (10mg/kg)+Olaparib maintenance
Experimental: Cohort 1-10B (non-BRCAm)
AK112(10mg/kg)+chemo for 4-6cycles, AK112(10mg/kg) maintenance
Experimental: Cohort 1-20A (BRCAm)
AK112(20mg/kg)+chemo for 4-6cycles, AK112(20mg/kg)+Olaparib maintenance
Experimental: Cohort 1-20B (non-BRCAm)
AK112(20mg/kg)+chemo for 4-6cycles, AK112(20mg/kg) maintenance
Experimental: Cohort 2 (Prior ≥2L)
AK112(20mg/kg)+Olaparib
Related Therapeutic Areas
Sponsors
Leads: Akeso

This content was sourced from clinicaltrials.gov