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Solid TumorPhase 1NCT05173792

Study of AK119 in Subjects With Advanced Solid Tumors

A Phase 1 study testing AK119 in people with Solid Tumor, 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

This is Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 (Anti-CD73) in Subjects with Advanced or Metastatic Solid Tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
AK119
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesChina
Study dates
22 Dec 2021to 22 May 2023
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to1.
  • Life expectancy ≥12 weeks;
  • Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and within 120 days after the last dose of investigational product.
  • Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and within 120 days after the last dose of investigational product.
  • Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor that is refractory or relapsed to the current standard therapies, or for which no effective standard therapy is available, or whereby standard therapy has been refused.
  • Subjects must have evaluable lesions according to RECIST v1.1.
  • Adequate organ function.

Who cannot join

  • Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured.
  • Receipt of the following treatments or procedures:
  • Anticancer small-molecule targeted agent (e.g., tyrosine kinase inhibitor) within 2 weeks prior to the first dose of investigational product;
  • Anti-PD-1/PD-L1 mAb within 4 weeks prior to the first dose of investigational product;
  • Prior use of approved or investigational anti-CTLA-4 therapy, anti-CD73 therapy or adenosine 2A receptor inhibitors, or any other antibody or drug targeting T cell costimulation or immune checkpoint pathways such as ICOS, or agonists such as CD40, CD137, GITR, OX40 etc.;
  • Other anticancer mAb within 4 weeks or 5 half-lives (whichever is less) prior to the first dose of investigational product;
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  • Other anticancer therapy (e.g., chemotherapy, radiotherapy, etc.) within 4 weeks prior to the first dose of investigational product;
  • Any major surgery within 4 weeks prior to the first dose of investigational product;
  • Any other non-approved investigational product or procedure within 4 weeks prior to the first dose of investigational product, or concurrent participation in another therapeutic clinical study;
  • Any topical therapy (e.g., TACE, HAIC, TARE) within 4 weeks prior to the first dose of investigational product;
  • Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at Screening;
  • Brain stem metastasis, meningeal metastasis, spinal cord metasasis or compression;
  • Uncontrolled massive ascites, pleural effusion or pericardial effusion, as determined by the Investigator;
  • Known history of human immunodeficiency virus (HIV) infection;
  • Known active hepatitis B or C infections (Active hepatitis B is defined as a known positive Hepatitis B surface antigen [HBsAg] result. Active hepatitis C is defined by a known positive Hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results);
  • Active autoimmune diseases or history of autoimmune diseases that may relapse;
  • History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies;
  • Patients with clinically significant cardio-cerebrovascular or venous thromboembolic disease;
  • Toxicities of prior anticancer therapy have not resolved to NCI-CTCAE version 5.0 Grade ≤1, or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities);
  • History of severe hypersensitivity reactions to other mAbs;
  • Prior organ transplantation;
  • Any condition that required systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product;
  • Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product; Note: seasonal vaccine for influenza which is generally inactivated is allowed;
  • Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fudan University Zhongshan Hospital

    Shanghai, 200032

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

Other trials in China

About this study

Official title: A Phase I, Multicenter, Open-Label, Dose-escalation and Dose-exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of of AK119 (CD73) in Subjects With Advanced Solid Tumors

This is Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 (Anti-CD73) in Subjects with Advanced or Metastatic Solid Tumors.

Conditions
Solid Tumor
Being tested
AK119

What participants receive

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

  • AK119Drug

    Subjects will receive AK119 intravenously.

Study groups in NCT05173792
Study groupRoleWhat they receive
AK119ExperimentalSubjects will receive escalating doses of AK119 every 2 or 3 weeks.
Receives: Drug: AK119

What is being measured

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

  1. Number of participants with adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

    Measured: From the time of informed consent signed through 90 days after the last dose of study drug

  2. Number of participants with a Dose Limiting Toxicity (DLT)

    DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and first 3 weeks for dose-exploration phase. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

    Measured: During the first 4 weeks in dose-escalation phase, during the first 3 weeks in dose-exploration phase

Secondary outcomes (5)

  1. Serum PK concentration of AK119

    Serum PK concentration of AK119 in individual subjects at different time points after AK119 administration.

    Measured: From first dose of study drug through 30 days after last dose of study drug

  2. Number of subjects who develop detectable anti-drug antibodies (ADAs)

    The immunogenicity of AK119 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

    Measured: From first dose of study drug through 90 days after last dose of study drug

  3. Objective response rate (ORR)

    ORR is defined as the proportion of subjects with confirmed CR or confirmed PR.

    Measured: Up to 2 years

  4. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or SD.

    Measured: Up to 2 years

  5. Progression-free survival (PFS)

    PFS is defined as the time from the start of treatment with AK119 until the first documentation of disease progression or death due to any cause, whichever occurs first.

    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 posted30 Dec 2021
  2. Study start22 Dec 2021
  3. Primary completion22 May 2023
  4. Study completion22 May 2023

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173792
Sponsor's protocol ID
AK119-103
Status last verified
Apr 2024
First submitted
23 Nov 2021
Last updated
25 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK119 in people with Solid Tumor, 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 8 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: finished, as of the sponsor's last update on 25 Apr 2024. 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 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.

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?

Number of participants with adverse events (AEs) (time frame: From the time of informed consent signed through 90 days after the last dose of study drug). 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 NCT05173792.

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 25 Apr 2024.

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