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Recurrent Ovarian CancerPhase 2NCT06560112

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

A Phase 2 study testing AK104, AK112 and Chemotherapy in people with Recurrent Ovarian Cancer, run by Akeso at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Ovarian Cancer
What is being tested?
AK104, AK112 and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteChina
Study dates
12 Nov 2024to 1 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subjects with active hepatitis B and active viral hepatitis C.
  • Active or documented inflammatory bowel diseases, active diverticulitis.
  • Patients with clinically significant cardio-cerebrovascular disease.
  • Unresolved toxicities from prior anticancer therapy.
  • History of severe hypersensitivity reactions to other mAbs.
  • Pregnant or lactating women.
  • Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug.
  • Exclusion Criteria for Chemotherapy-Related Cohorts (Cohorts 1,2,4): Known contraindications or allergy to PLD, paclitaxel or topotecan.
  • Exclusion Criteria for AK112-Related Cohorts (Cohorts 2,3,4): Known contraindications or allergy to any component of VEGF mABs or any medical conditions that affect the safety of AK112.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ting Liu, M.D. contact

(0760)89873999

clinicaltrials@akesobio.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Xiaohua Wu, MD

    Xiaohua Wu, MD

    Recruiting

Other trials in China

About this study

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

Read the detailed description

This is a Phase 2, open label, multicohort, multicenter study designed to evaluate the efficacy and safety of combination therapy of AK104, AK112 and chemotherapy in recurrent ovarian cancer.

AK104 is a bispecific monoclonal antibody targeting both CTLA-4 and PD-1. AK112 is a bispecific monoclonal antibody targeting VEGF and PD-1.

Being tested
AK104, AK112, Chemotherapy
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK104Drug

    Also called Cadonilimab

    ivgtt

  • AK112Drug

    Also called Ivonescimab

    ivgtt

  • ChemotherapyDrug

    Also called Monotherapy Non-Platinum Chemotherapy chosen by the investigator

    ivgtt

Study groups in NCT06560112
Study groupRoleWhat they receive
Cohort 1ExperimentalAK104 q3w +Chemo
Receives: Drug: AK104; Drug: Chemotherapy
Cohort 2ExperimentalAK112 q3w +Chemo
Receives: Drug: AK112; Drug: Chemotherapy
Cohort 3ExperimentalAK112 q3w +AK104 q6w
Receives: Drug: AK104; Drug: AK112
Cohort 4ExperimentalAK112 q3w +AK104 q6w +Chemo
Receives: Drug: AK104; Drug: AK112; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 2 years

Secondary outcomes (5)

  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.

    Measured: Up to 2 years

  2. duration of Response (DOR) assessed by investigator per RECIST v1.1

    DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

    Measured: Up to 2 years

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

    TTR refers to Time to Response.

    Measured: Up to 2 years

  4. Overall Survival(OS)

    OS is defined as the time from randomization or first dosing to death due to any cause.

    Measured: Up to 2 years

  5. Number of participants with adverse event (AE)

    The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start12 Nov 2024
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560112
Sponsor's protocol ID
AK104-221
Status last verified
Mar 2025
First submitted
15 Aug 2024
Last updated
12 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK104, AK112 and Chemotherapy in people with Recurrent Ovarian Cancer, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ting Liu, M.D. ((0760)89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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