An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent 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 With AK104 and AK112 for Recurrent Ovarian Cancer

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 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Ting Liu, M.D.
clinicaltrials@akesobio.com
(0760)89873999
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 172
Treatments
Experimental: Cohort 1
AK104 q3w +Chemo
Experimental: Cohort 2
AK112 q3w +Chemo
Experimental: Cohort 3
AK112 q3w +AK104 q6w
Experimental: Cohort 4
AK112 q3w +AK104 q6w +Chemo
Related Therapeutic Areas
Sponsors
Leads: Akeso

This content was sourced from clinicaltrials.gov

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