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Ovarian NeoplasmsPhase 1/2NCT04999605

A Study of AK112 Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer

A Phase 1/2 study testing AK112 low dose, AK112 medium dose and AK112 high dose in people with Ovarian Neoplasms and Recurrent Ovarian Carcinoma, run by Akeso at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with PARP inhibitor in patients with recurrent ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
AK112 low dose, AK112 medium dose and AK112 high dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
24 Jun 2021to 10 Jun 2022
Phase
Phase 1/2
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 years old to ≤ 75 years old at study enrollment, female subjects.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Have a life expectancy of at least 3 months.
  • Have histologically or cytologically diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Have received at least two lines of platinum-containing treatment (bevacizumab or its biosimilars was allowed), and were platinum-sensitive recurrence (progression more than 6 months after the last dose of platinum-containing regimen).
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  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by investigator.
  • 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, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
  • Able to to comply with all requirements of study participation (including all study procedures).

Who cannot join

  • Previous history (within five years) or concurrent malignant neoplasm, except that basal cell carcinoma and/or squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ or breast cancer in situ that has undergone curative therapy.
  • Participation in a study of an investigational drug or using an investigational device within 4 weeks of first study drug administration.
  • Ovarian, fallopian tube or primary peritoneal cancer cancer of non-epithelial origin (such as germ cell carcinoma).
  • Previous targeted therapy using small molecules (except PARP inhibitors) and/or immunotherapy.
  • Have a potent or moderate CYP3A inhibitor, or a potent or moderate CYP3A inducer within 1 week prior to first study drug administration (or 5 drug half-lives, whichever is longer).
  • 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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  • Active or previous history of inflammatory bowel disease such as Crohn's disease, ulcerative colitis or chronic diarrhea.
  • History of immunodeficiency and/or HIV antibody positive subjects.
  • Has severe infection 4 weeks prior to first study drug administration, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to first study drug administration (excluding antiviral therapy for hepatitis B or C).
  • Has known active Hepatitis B that is untreated and requiring antiviral therapy during study period; or active Hepatitis C subjects (HCV antibody positive with HCV-RNA levels above the detection threshold).
  • Has undergone major surgery or severe trauma within 30 days prior to the first study drug administration.
  • Has known active central nervous system (CNS) metastases.
  • Uncontrolled co-morbidities including but not limited to symptomatic congestive heart failure (NYHA≥2), unstable angina, acute myocardial infarction, poorly controlled arrhythmias, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe peptic ulcer disease or gastritis.
  • Uncontrolled hypertension despite optimal medical treatment; history of hypertensive crisis or hypertensive encephalopathy.
  • Any arterial thromboembolism, transient ischemic attack, cerebrovascular accident occurred within 6 months prior to the first study drug administration.
  • History of abdominal fistula or gastrointestinal perforation associated with anti-VEGF therapy; imaging results revealed invasion of the intestinal wall by tumor during screening.
  • Imaging or clinical findings of gastrointestinal obstruction, including incomplete obstruction.
  • Unable to swallow tablets or has had gastrointestinal abnormalities that may affect drug absorption as determined by the investigator.
  • Has had live vaccine within 30 days prior to first study drug administration or plan to receive live vaccine during the study period.
  • Has known psychiatric or substance abuse disorders, including alcohol or drug abuse.
  • Pregnant or lactating female subject.
  • Any prior or concurrent disease, treatment, or laboratory test abnormality that may confuse study results, affect subjects' full participation in the study, or may not be in their best interest to participate.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: Phase Ib/II Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody (AK112) Combined With PARP Inhibitor in the Treatment of Recurrent Ovarian Cancer

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with PARP inhibitor in patients with recurrent ovarian cancer.

Being tested
AK112 low dose, AK112 medium dose, AK112 high dose
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • AK112 low doseDrug

    AK112 injection low dose+ olaparib (Lynparza®) PARP inhibitor

  • AK112 medium doseDrug

    AK112 injection medium dose+ olaparib (Lynparza®) PARP inhibitor

  • AK112 high doseDrug

    AK112 injection high dose+ olaparib (Lynparza®) PARP inhibitor

Study groups in NCT04999605
Study groupRoleWhat they receive
AK112ExperimentalAK112 injection
Receives: Drug: AK112 low dose; Drug: AK112 medium dose; Drug: AK112 high dose

What is being measured

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

  1. Safety endpoint: number of subjects with adverse events (AE)

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: Up to approximately 2 years

  2. Primary efficacy endpoint: objective response rate (ORR)

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) assessed according to RECIST v1.1

    Measured: Up to approximately 2 years

Secondary outcomes (8)

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

    DCR based on RECIST v1.1. DCR is defined as the proportion of subjects with CR, PR, or SD.

    Measured: Up to approximately 2 years

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

    PFS based on RECIST v1.1. PFS is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first)

    Measured: Up to approximately 2 years

  3. Efficacy Endpoint assessed according to RECIST v1.1 : Overall survival (OS)

    OS based on RECIST v1.1. OS is defined as the time from the date of randomization or first dosing date to death due to any cause

    Measured: Up to approximately 2 years

  4. Serum PK concentrations of AK112

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

    Measured: Up to approximately 2 years

  5. To evaluate the immunogenicity of AK112: Number of subjects with anti-drug antibodies (ADA)

    Immunogenicity of AK112: Number of subjects with detectable anti-drug antibodies (ADA)

    Measured: Up to approximately 2 years

  6. To evaluate the immunogenicity of AK112: Percentage of subjects with anti-drug antibodies (ADA)

    Immunogenicity of AK112: Percentage of subjects with detectable anti-drug antibodies (ADA)

    Measured: Up to approximately 2 years

  7. To evaluate the correlation between the expression of PD-L1 and the antitumor activity of AK112 in tumor tissues

    Correlation between PD-L1 and AK112 in tumor tissues

    Measured: Up to approximately 2 years

  8. To evaluate the association between gBRCA1/2 mutation in peripheral blood and the antitumor activity of AK112 in subjects with recurrent ovarian cancer

    Association between gBRCA1/2 mutation in peripheral blood and antitumor activity of AK112

    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 posted11 Aug 2021
  2. Study start24 Jun 2021
  3. Primary completion10 Jun 2022
  4. Study completion10 Jun 2022

Why it stopped: Too low inclusion rate

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04999605
Sponsor's protocol ID
AK112-204
Status last verified
Jan 2024
First submitted
29 Apr 2021
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
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 1/2 study testing AK112 low dose, AK112 medium dose and AK112 high dose in people with Ovarian Neoplasms and Recurrent Ovarian Carcinoma, 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 22 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: Too low inclusion rate). Results are not available in the source record.

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?

Safety endpoint: number of subjects with adverse events (AE) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. 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 NCT04999605.

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 5 Jan 2024.

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