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Neoplasms MalignantPhase 1NCT04349969

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104

A Phase 1 study testing AK117 and AK117+AK104 in people with Neoplasms Malignant, run by Akesobio Australia Pty Ltd at 4 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 was a first-in-human, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK117 as monotherapy or in combination with AK104 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
Neoplasms Malignant
What is being tested?
AK117 and AK117+AK104
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
4 sitesAustralia
Study dates
23 Apr 2020to 8 Nov 2022
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

  • Able to provide written and signed informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
  • Life expectancy ≥12 weeks
  • Females of childbearing potential and non-sterilized males who are sexually active must use an effective method of contraception from screening until 120 days after final dose of investigational product or women of non-childbearing potential.
  • Willing to receive blood transfusion(s) when so advised by the investigator.
  • Adequate organ function.
  • Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies or which no effective standard therapy is available.
  • At least 1 measurable lesion according to RECIST v1.1

Who cannot join

  • Concurrent enrollment in another clinical study excluding observational trials
  • Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study
  • Active brain/central nervous system (CNS) metastases
  • Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
  • Known history of HIV.
  • Known active hepatitis B or C infections
Show all 15Show fewer
  • Active or prior documented autoimmune disease that may relapse.
  • History of interstitial lung disease or non-infectious pneumonitis, except those induced by radiation therapies.
  • History of defects in RBC production, or hemoglobin production or metabolism
  • Patients with clinically significant cardio-cerebrovascular disease.
  • History of severe hypersensitivity reactions to other mAbs.
  • History of organ transplantation.
  • Receiving any anticancer therapy targeting the CD47/SIRPα ; Anticancer small molecule targeted agent within 2 weeks prior to the first dose of the investigational product; Anticancer mAbs within 6 weeks prior to the first dose of investigational product or 5 half-lives (whichever is lesser); Other anticancer therapy within 4 weeks prior to the first dose of the investigational product;
  • Subjects with a condition requiring systemic treatment with either corticosteroid (>10 mg daily doses)) or other immunosuppressive medications within 2 weeks prior to the first dose of investigational product.
  • Received a live attenuated vaccine within 4 weeks prior to the first dose of investigational product.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Austin Health

    Heidelberg, Victoria

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia

  • ICON Cancer Foundation

    South Brisbane, Queensland

  • Blacktown Hospital

    Sydney, New South Wales

Other trials in Australia

About this study

Official title: A Phase 1 Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104 in Subjects With Relapsed/Refractory Advanced or Metastatic Solid Tumors or Lymphomas

This was a first-in-human, Phase 1 study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK117 as monotherapy or in combination with AK104 in subjects with advanced or metastatic solid tumors.

Read the detailed description

The study was conducted across 2 parts. Part A of the study was the dose escalation part of AK117 monotherapy as priming dose to evaluate the safety and tolerability of AK117 weekly dosing in solid tumors. Part B which was to evaluate the optimal maintenance dose of AK117 was not performed as the MAD dose level of AK117 monotherapy was determined in Part A.

Part A2 was the dose escalation part of AK117 in combination with AK104 to evaluate the safety and tolerability of AK117 monotherapy in solid tumors.

Being tested
AK117, AK117+AK104
Keywords
Antineoplastic Agents, Immunological
Medical subject headings
Neoplasms

What participants receive

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

  • AK117Drug

    All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal.

  • AK117+AK104Drug

    All Subjects will receive 3 weekly infusions of AK117 (Days 1, 8, and 15) and 1 infusion of AK104 (on Day 1) as combination therapy in each 21-day treatment cycle until unacceptable toxicity, documentation of confirmed PD, or subject withdrawal.

Study groups in NCT04349969
Study groupRoleWhat they receive
TreatmentExperimentalParts A and B: AK117 monotherapy intravenous (IV) infusion- weekly doses in a 28-day cycle. Parts A2: AK117 (QW) + AK104 (Q3W) combination therapy intravenous (IV) infusion in a 21-day cycle.
Receives: Drug: AK117; Drug: AK117+AK104

What is being measured

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

  1. Incidence and nature of 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 30 days after the last dose of AK117 as monotherapy or in combination with AK104

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

    DLTs will be assessed during the first 4 weeks (AK117 monotherapy) or first 3 weeks (AK117+AK104 combination therapy) 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 of treatment.

    Measured: During the first 4 weeks of first treatment dose of AK117 as monotherapy or during the first 3 weeks of treatment dose of AK117+AK104 as combination therapy.

Secondary outcomes (6)

  1. Objective response rate (ORR)

    ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by Investigator per RECIST Version 1.1.

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    (subjects achieving SD will be included in the DCR if they maintain SD for 16 and 24 weeks respectively).

    Measured: Up to 2 years

  3. Maximum observed concentration (Cmax) of AK117 as monotherapy or in combination with AK104 and Minimum observed concentration (Cmin) of AK117 at steady stateconcentration (Cmin) of AK117 at steady state

    The endpoints for assessment of PK of AK117 and AK104 include serum concentrations of AK117 and AK104 at different timepoints after AK117 and AK104 administration.

    Measured: From first dose through to 30 days after last dose of investigational products.

  4. Number of subjects who develop detectable anti-drug antibodies (ADAs) of AK117 as monotherapy or in combination with AK104

    The immunogenicity of AK117 and AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

    Measured: From first dose through to 30 days after last dose of investigational products.

  5. Area under the curve (AUC) of AK117 as monotherapy or in combination with AK104 for assessment of pharmacokinetics

    The endpoints for assessment of PK of AK117 and AK104 include serum concentrations of AK117 and AK104 at different timepoints after AK117 and AK104 administration.

    Measured: From first dose through to 30 days after last dose of investigational products.

  6. Receptor occupancy (RO) of AK117 as monotherapy or in combination with AK104 to evaluate target engagement

    The endpoints will be measured using a flow cytometry-based method on circulating red and white blood cells.

    Measured: From first dose through to 30 days after last dose of investigational products.

Timeline

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

  1. First posted16 Apr 2020
  2. Study start23 Apr 2020
  3. Primary completion8 Nov 2022
  4. Study completion8 Nov 2022

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04349969
Sponsor's protocol ID
AK117-101
Status last verified
Aug 2024
First submitted
14 Apr 2020
Last updated
21 Aug 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 study testing AK117 and AK117+AK104 in people with Neoplasms Malignant, run by Akesobio Australia Pty Ltd at 4 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 8 inclusion and 15 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Incidence and nature of adverse events (AEs) (time frame: From the time of informed consent signed through 30 days after the last dose of AK117 as monotherapy or in combination with AK104). 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 NCT04349969.

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 21 Aug 2024.

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