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Advanced CancerPhase 1NCT03261011

Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK104 in Subjects With Advanced Solid Tumors

A Phase 1 study testing AK-104 in people with Advanced Cancer, run by Akesobio Australia Pty Ltd at 6 sites in Australia.

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 study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK104 as a single agent in adult subjects with advanced solid tumor malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
AK-104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
6 sitesAustralia
Study dates
3 Oct 2017to 13 Apr 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

  • Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
  • In dose-escalation cohorts (Phase 1a), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
  • In the dose-expansion cohorts (Phase 1b), histologically or cytologically confirmed selected advanced solid tumors (to be determined). Subjects must have received no more than three prior lines of systemic therapy for advanced or metastatic disease.
  • Subject must have at least one measurable lesion according to RECIST Version1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
  • Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy.
  • Adequate organ function.

Who cannot join

  • History of severe hypersensitivity reactions to other mAbs.
  • Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTL4 antibody or any other antibody or drug targeting T-cell costimulation or checkpoint pathways such as ICOS, or agonists such as CD40, CD137, GITR, OX40 etc.
  • Receipt of any immunotherapy, any conventional or investigational systemic anticancer therapy within 4 weeks prior to the first dose of AK104; in the case of mAbs, 6 weeks prior to the first dose of AK104.
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
  • Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
  • Active or prior documented autoimmune disease within the past 2 years.
Show all 17Show fewer
  • Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  • History of primary immunodeficiency.
  • History of organ transplant or hematopoietic stem cell that requires use of immunosuppressives.
  • Known allergy or reaction to any component of the AK104 formulation.
  • History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
  • Known history of tuberculosis.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection except for subjects with HCC.
  • An active infection requiring systemic therapy with the exception of anti-viral therapy for hepatitis as specified by the protocol.
  • Receipt of live or attenuated vaccination within 30 days prior to the first dose of AK104.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Australia6 sites

  • Monash Health

    Clayton, Victoria, 3168

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Austin Health

    Heidelberg, Victoria, 3084

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

  • Linear Clinical Research/Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Integrated Clinical Oncology Network (ICON)

    South Brisbane, Queensland, 4101

Other trials in Australia

About this study

Official title: A Phase 1A/1B Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK104 in Subjects With Advanced Solid Tumors

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK104 as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK104 as a single agent, and a dose expansion phase (Phase 1b) which will characterize treatment of AK104 as a single agent at the MTD or RP2D.

Conditions
Advanced Cancer
Being tested
AK-104
Keywords
immunotherapy, immuno-oncology, advanced solid tumors

What participants receive

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

  • AK-104Biological

    Subjects will receive AK104 by intravenous administration.

Study groups in NCT03261011
Study groupRoleWhat they receive
AK-104ExperimentalSingle-arm
Receives: Biological: AK-104

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 AK104, up to 2 years and 3 months

  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 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 first cycle (4 weeks) of treatment.

    Measured: During the first 4 weeks

Secondary outcomes (9)

  1. Objective response rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Measured: Up to 3 years

  2. Disease control rate (DCR)

    The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

    Measured: Up to 3 years

  3. Duration of response (DoR)

    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 3 years

  4. Progression-free survival (PFS)

    Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 3 years

  5. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause.

    Measured: Up to 3 years

  6. Area under the curve (AUC) of AK104

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.

    Measured: From first dose of AK104 through 90 days after last dose of AK104; Up to 2 years and 3 months.

  7. Maximum observed concentration (Cmax) of AK104

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.

    Measured: From first dose of AK104 through to 90 days after last dose of AK104; Up to 2 years and 3 months.

  8. Minimum observed concentration (Cmin) of AK104 at steady state

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.

    Measured: From first dose of AK104 through to 90 days after last dose of AK104; Up to 2 years and 3 months.

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

    The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

    Measured: From first dose of AK104 through to 90 days after last dose of AK104; Up to 2 years and 3 months.

Timeline

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

  1. First posted24 Aug 2017
  2. Study start3 Oct 2017
  3. Primary completion27 Aug 2021
  4. Study completion13 Apr 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
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261011
Sponsor's protocol ID
AK104-101
Status last verified
Feb 2025
First submitted
20 Aug 2017
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang J, Li X, Xiao G, Desai J, Frentzas S, Wang ZM, Xia Y, Li B. CD74 is associated with inflamed tumor immune microenvironment and predicts responsiveness to PD-1/CTLA-4 bispecific antibody in patients with solid tumors. Cancer Immunol Immunother. 2024 Jan 27;73(2):36. doi: 10.1007/s00262-023-03604-2.

    PubMed 38280003

  • Frentzas S, Gan HK, Cosman R, Coward J, Tran B, Millward M, Zhou Y, Wang W, Xia D, Wang ZM, Li B, Xia M, Desai J. A phase 1a/1b first-in-human study (COMPASSION-01) evaluating cadonilimab in patients with advanced solid tumors. Cell Rep Med. 2023 Nov 21;4(11):101242. doi: 10.1016/j.xcrm.2023.101242. Epub 2023 Oct 17.

    PubMed 37852261

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK-104 in people with Advanced Cancer, run by Akesobio Australia Pty Ltd at 6 sites in Australia.

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 7 inclusion and 17 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 6 sites in Australia. 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 AK104, up to 2 years and 3 months). 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 NCT03261011, which also lists 2 linked publications.

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.

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