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

NCT06686030 | Recruiting Phase 2

• 1 other identifier: AK112-211
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Conditions

Platinum-sensitive Ovarian Cancer

Keywords

platinum-sensitive ovarian cancer; PD-1; VEGF; antibody; AK112

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by investigator per RECIST v1.1

  PFS is defined as the time from the date of first dosing till the first documented disease progression Per RECIST v1.1 assessed by the investigator or death due to any cause, whichever occurs first.

  up to 2 years

Secondary Outcomes (6)

• Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator

  Up to 2 years

• Disease control rate(DCR)assessed by investigator per RECIST v1.1

  Up to 2 years

• Duration of Response (DOR) assessed by investigator per RECIST v1.1

  Up to 2 years

• Time to Response (TTR) assessed by investigator per RECIST v1.1

  Up to 2 years

• Overall Survival(OS)

  Up to 2 years

Study Arms (5)

Cohort 1-10 (BRCAm)

EXPERIMENTAL

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

Drug: AK112 low dose; Drug: Chemotherapy; Drug: Olaparib

Cohort 1-10B (non-BRCAm)

EXPERIMENTAL

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

Drug: AK112 low dose; Drug: Chemotherapy

Cohort 1-20A (BRCAm)

EXPERIMENTAL

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

Drug: Chemotherapy; Drug: Olaparib; Drug: AK112 high dose

Cohort 1-20B (non-BRCAm)

EXPERIMENTAL

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

Drug: Chemotherapy; Drug: AK112 high dose

Cohort 2 (Prior ≥2L)

EXPERIMENTAL

AK112(20mg/kg)+Olaparib

Drug: Olaparib; Drug: AK112 high dose

Interventions

AK112 low dose DRUG

10mg/kg, Q3W, ivgtt

Also known as: Ivonescimab

Cohort 1-10 (BRCAm); Cohort 1-10B (non-BRCAm)

Chemotherapy DRUG

ivgtt

Cohort 1-10 (BRCAm); Cohort 1-10B (non-BRCAm); Cohort 1-20A (BRCAm); Cohort 1-20B (non-BRCAm)

Olaparib DRUG

bid, oral

Cohort 1-10 (BRCAm); Cohort 1-20A (BRCAm); Cohort 2 (Prior ≥2L)

AK112 high dose DRUG

20mg/kg, Q3W, ivgtt

Cohort 1-20A (BRCAm); Cohort 1-20B (non-BRCAm); Cohort 2 (Prior ≥2L)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other pathological types such as mucinous cancer, sex cord stromal cell tumor, etc.
• Presence of central nervous system (CNS) metastases or carcinomatous meningitis.
• Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.
• Subjects with other active malignancies within 3 years prior to randomization.
• Received systemic anti-tumor therapy within 2 weeks prior to randomization.
• Any prior treatments targeting the mechanism of tumor immunity.
• Major surgical , open biopsy or significant trauma within 4 weeks prior to randomization; or elective major surgical treatment required during the study.
• Active or potentially recurrent autoimmune disease.
• 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.
• Receiving live vaccines within 4 weeks prior to randomization.
• Known primary or secondary immunodeficiencies, including testing positive for human immunodeficiency virus (HIV) antibodies.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Known history of interstitial lung disease or non-infectious pneumonitis.
• Serious infections requiring hospitalization.
• Presence of active infection requiring systemic therapy.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science And Technology

Wuhan, 430000, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy; olaparib

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Ting Liu, M.D.

CONTACT

(0760)89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (1)