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Gynecologic CancerPhase 2NCT04870177

Study of AK112 in the Treatment of Advanced Gynecological Tumors

A Phase 2 study testing AK112 in people with Gynecologic Cancer and Cancer Metastatic, run by Akeso at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase II study to evaluate the efficacy and safety of AK112 in subjects with advanced gynecological tumors. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
AK112
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesChina
Study dates
9 Apr 2021to 10 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be able and willing to provide written informed consent
  • 18 to 75 years old of age during enrollment
  • Has ECOG performance status of 0 or 1
  • Has a life expectancy of at least 3 months
  • Confirmed diagnosis of advanced gynaecological neoplasm
  • Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator
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  • Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy
  • Has adequate organ functions (e.g hematology, renal, hepatic and coagulation)
  • All female subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment
  • Be able and willing to comply with all requirements of study participation (including all study procedures)

Who cannot join

  • Known history of other malignancy (in the last 5 years) except localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, breast carcinoma in situ that has undergone curative therapy and breast carcinoma that has not recurred for > 3 years after radical surgery
  • Is currently participating in a study of an investigational agent or using an investigational device 4 weeks prior to first administration of study drug
  • For patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, prior abdominal and pelvic radiation therapy was performed
  • For recurrent/metastatic endometrial carcinoma, subjects had carcinosarcomas (malignant mixed Mullerian tumors), endometrial leiomyosarcomas or other high-grade sarcomas, or endometrial stromal sarcomas
  • Ovarian carcinoma of non-epithelial origin, fallopian tube cancer, primary peritoneal carcinoma (e.g., germ cell tumor); Ovarian neoplasms with low malignancy potential (e.g. borderline neoplasms)
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
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  • Previous history of immunodeficiency; HIV antibody positive; Current long-term use of systemic corticosteroids or other immunosuppressants
  • Severe infection, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia, occurs within 4 weeks prior to the first administration of the study drug; Active infection with systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within two weeks prior to first administration of study drug
  • Untreated active hepatitis B subjects; subjects with hepatitis B are required to receive anti-HBV therapy during the study period; active hepatitis C subjects
  • Has undergone major surgery within 30 days prior to the first dose of study treatment
  • Has known active central nervous system (CNS) metastases
  • Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure, or vascular disease requiring hospitalization (such as aortic aneurysm at risk of rupture), or other cardiac impairment (such as poorly controlled arrhythmias, myocardial ischemia) that may affect study drug safety evaluation within 12 months prior to first administration of study drug
  • Previous history of abdominal fistula or gastrointestinal perforation associated with anti-VEGF therapy; the imaging results revealed the invasion of intestinal wall by neoplasm during screening
  • During screening, imaging or clinical findings of gastrointestinal obstruction, including incomplete obstruction
  • Previous history of severe bleeding or coagulation disorders; during screening, imaging showed that the neoplasm surrounded major blood vessels or had obvious necrosis and cavitation, and the investigators believed that participation in the study might increase risk of bleeding
  • Has received a live virus vaccine within 30 days prior to first administration of study drug or plan to be administered during the study period
  • Has known psychiatric or substance abuse disorders
  • Is pregnant, breastfeeding women
  • Any prior or current disease, treatment, or laboratory test abnormality that may confound the study endpoints, interfere with subjects' full participation in the study, or may not be in their best interest to participate in this study

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Qilu Hospital of Shandong University

    Qilu, Shandong, 250012

Other trials in China

About this study

Official title: Phase II Study of AK112 (Anti-PD-1 and VEGF Bi-specific Antibody) in the Treatment of Advanced Gynecological Carcinoma

A phase II study to evaluate the efficacy and safety of AK112 in subjects with advanced gynecological tumors.

Being tested
AK112
Medical subject headings
Neoplasm Metastasis, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms

What participants receive

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

  • AK112Drug

    AK112 infusion biweekly

Study groups in NCT04870177
Study groupRoleWhat they receive
Advanced gynecological neoplasmsExperimentalNot described
Receives: Drug: AK112

What is being measured

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

  1. Objective response rates (ORR) according to RECIST v1.1 in the FAS population

    Measured: Up to approximately 2 years

Secondary outcomes (11)

  1. Efficacy endpoint: disease control rate (DCR) assessed according to RECIST v1.1

    Measured: Up to approximately 2 years

  2. Efficacy endpoint: duration of response (DOR) assessed according to RECIST v1.1

    Measured: Up to approximately 2 years

  3. Efficacy endpoint: time to response (TTR) assessed according to RECIST v1.1

    Measured: Up to approximately 2 years

  4. Efficacy endpoint: progression-free survival (PFS) assessed according to RECIST v1.1

    Measured: Up to approximately 2 years

  5. Efficacy endpoint: overall survival (OS) assessed according to RECIST v1.1

    Measured: Up to approximately 2 years

  6. Serum PK concentrations of AK112 in individual subjects at different time points after AK112 administration

    Measured: Up to approximately 2 years

  7. Number of subjects with detectable anti-drug antibodies (ADA)

    Measured: Up to approximately 2 years

  8. Percentage of subjects with detectable anti-drug antibodies (ADA)

    Measured: Up to approximately 2 years

  9. Correlation between the expression of PD-L1 and the antitumor activity of AK112 in tumor tissues

    Measured: Up to approximately 2 years

  10. Correlation between microsatellite instability (MSI) and mismatch repair defect (DMMR) in tumor tissue samples from patients with endometrial cancer and the antitumor activity of AK112

    Measured: Up to approximately 2 years

  11. The association between BRCA1/2 mutation and AK112 antitumor activity in peripheral blood samples and tumor tissues from patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer

    Measured: Up to approximately 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 posted3 May 2021
  2. Study start9 Apr 2021
  3. Primary completion10 May 2024
  4. Study completion10 May 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04870177
Sponsor's protocol ID
AK112-203
Status last verified
Feb 2025
First submitted
5 Apr 2021
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK112 in people with Gynecologic Cancer and Cancer Metastatic, run by Akeso at 2 sites 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 10 inclusion and 19 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rates (ORR) according to RECIST v1.1 in the FAS population (time frame: Up to approximately 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 NCT04870177.

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 28 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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