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

NCT06560112 | Recruiting Phase 2

• 1 other identifier: AK104-221
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

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

  Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria

  Up to 2 years

Secondary Outcomes (5)

• progression-free survival (PFS) 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

• Number of participants with adverse event (AE)

  Up to 2 years

Study Arms (4)

Cohort 1

EXPERIMENTAL

AK104 q3w +Chemo

Drug: AK104; Drug: Chemotherapy

Cohort 2

EXPERIMENTAL

AK112 q3w +Chemo

Drug: AK112; Drug: Chemotherapy

Cohort 3

EXPERIMENTAL

AK112 q3w +AK104 q6w

Drug: AK104; Drug: AK112

Cohort 4

EXPERIMENTAL

AK112 q3w +AK104 q6w +Chemo

Drug: AK104; Drug: AK112; Drug: Chemotherapy

Interventions

AK104 DRUG

ivgtt

Also known as: Cadonilimab

Cohort 1; Cohort 3; Cohort 4

AK112 DRUG

ivgtt

Also known as: Ivonescimab

Cohort 2; Cohort 3; Cohort 4

Chemotherapy DRUG

ivgtt

Also known as: Monotherapy Non-Platinum Chemotherapy chosen by the investigator

Cohort 1; Cohort 2; Cohort 4

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 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.

You may not qualify if:

• Other pathological types such as mucinous cancer, low-grade serous carcinoma, carcinosarcoma, 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.
• Patients with other active malignancies within 3 years prior to randomization.
• Received systemic anti-tumor therapy within 3 weeks prior to randomization.
• Any prior treatments targeting the mechanism of tumor immunity.
• Major surgical treatment, 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.
• Use of 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)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

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: August 15, 2024
• First Posted: August 19, 2024
• Study Start: November 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)