Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer

NCT ID: NCT06686030

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2028-07-31

Brief Summary

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

Detailed Description

This is a Phase 2, open label, multicohort, multicenter study designed to evaluate the efficacy and safety of combination of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer. AK112 is a bispecific monoclonal antibody targeting VEGF and PD-1.

Conditions

Platinum-sensitive Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1-10 (BRCAm)

AK112(10mg/kg)+chemo for 4-6 cycles, AK112 (10mg/kg)+Olaparib maintenance

Group Type: EXPERIMENTAL

AK112 low dose

Intervention Type: DRUG

10mg/kg, Q3W, ivgtt

Chemotherapy

Intervention Type: DRUG

ivgtt

Olaparib

Intervention Type: DRUG

bid, oral

Cohort 1-10B (non-BRCAm)

AK112(10mg/kg)+chemo for 4-6cycles, AK112(10mg/kg) maintenance

Group Type: EXPERIMENTAL

AK112 low dose

Intervention Type: DRUG

10mg/kg, Q3W, ivgtt

Chemotherapy

Intervention Type: DRUG

ivgtt

Cohort 1-20A (BRCAm)

AK112(20mg/kg)+chemo for 4-6cycles, AK112(20mg/kg)+Olaparib maintenance

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

ivgtt

Olaparib

Intervention Type: DRUG

bid, oral

AK112 high dose

Intervention Type: DRUG

20mg/kg, Q3W, ivgtt

Cohort 1-20B (non-BRCAm)

AK112(20mg/kg)+chemo for 4-6cycles, AK112(20mg/kg) maintenance

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

ivgtt

AK112 high dose

Intervention Type: DRUG

20mg/kg, Q3W, ivgtt

Cohort 2 (Prior ≥2L)

AK112(20mg/kg)+Olaparib

Group Type: EXPERIMENTAL

Olaparib

Intervention Type: DRUG

bid, oral

AK112 high dose

Intervention Type: DRUG

20mg/kg, Q3W, ivgtt

Interventions

AK112 low dose

10mg/kg, Q3W, ivgtt

Intervention Type: DRUG

Chemotherapy

ivgtt

Intervention Type: DRUG

Olaparib

bid, oral

Intervention Type: DRUG

AK112 high dose

20mg/kg, Q3W, ivgtt

Intervention Type: DRUG

Other Intervention Names

Ivonescimab

Eligibility Criteria

Inclusion Criteria

1. Signs the written informed consent form.

2. Female participants who are at least 18 years of age on the day of signing informed consent with.

3. ECOG of 0 or 1.

4. Life expectancy ≥3 months.

5. 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:

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

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

6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team.

7. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue.

8. Has adequate organ function.

9. 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

1. Other pathological types such as mucinous cancer, sex cord stromal cell tumor, etc.

2. Presence of central nervous system (CNS) metastases or carcinomatous meningitis.

3. Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.

4. Subjects with other active malignancies within 3 years prior to randomization.

5. Received systemic anti-tumor therapy within 2 weeks prior to randomization.

6. Any prior treatments targeting the mechanism of tumor immunity.

7. Major surgical , open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.

8. Active or potentially recurrent autoimmune disease.

9. 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.

10. Receiving live vaccines within 4 weeks prior to randomization.

11. Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies.

12. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

13. Known history of interstitial lung disease or non-infectious pneumonitis.

14. Serious infections requiring hospitalization.

15. Presence of active infection requiring systemic therapy.

16. Subjects with active hepatitis B and active viral hepatitis C.

17. Active or documented inflammatory bowel diseases, active diverticulitis.

18. Subjects with clinically significant cardio-cerebrovascular disease.

19. Unresolved toxicities from prior anticancer therapy.

20. History of severe hypersensitivity reactions to other mAbs.

21. Pregnant or lactating women.

22. Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Union Hospital Tongji Medical College Huazhong University of Science And Technology

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ting Liu, M.D.

Role: CONTACT

clinicaltrials@akesobio.com

(0760)89873999

Facility Contacts

Qinglei Gao, MD

Role: primary

Other Identifiers

AK112-211

Identifier Type: -

Identifier Source: org_study_id