Advanced or Metastatic Solid TumorsPhase 1NCT05200273
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114
A Phase 1 study testing AK114 in people with Advanced or Metastatic Solid Tumors and Malignancy, run by Akeso at 1 site in Australia.
Trial summary
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors, Malignancy, Metastasis
- What is being tested?
- AK114
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Mar 2022to 30 Dec 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
- Age ≥ 18
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor
- Subject must have at least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1
- At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated
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- Available archived tumor tissue sample (block or a minimum of 10 unstained slides of formalin-fixed paraffin-embedded tissues) to allow for correlative biomarker studies
- Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate
- Adequate organ function
- Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product
Who cannot join
- History of severe hypersensitivity reactions to other monoclonal antibodies
- History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events
- Patients with clinically significant cardiovascular disease
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of investigational product administration
- Active or prior documented autoimmune disease within the past 2 years
- History of primary immunodeficiency
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- History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications
- Known allergy or reaction to any component of the investigational product formulation.
- History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies.
- Prior treatment with canakinumab.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.
Read the detailed description
This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunogenicity in adult subjects with advanced or metastatic solid tumors. The study is comprised of dose escalation phase. Approximately 30 subjects will be treated in this study.
- Conditions
- Advanced or Metastatic Solid Tumors, Malignancy, Metastasis
- Being tested
- AK114
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK114Drug
AK114 administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | Experimental Receives: Drug: AK114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence 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 drug, whether or not considered related to the study drug.
Measured: From the time of informed consent signed through to 90 days after last dose of study drug
Number of participants with a Dose Limiting Toxicity (DLTs)
DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
Measured: Within the first 28 days after receiving the first dose of study drug
Secondary outcomes (4)
Serum pharmacokinetics (PK)
Serum concentrations of study drug in individual subjects at different time points after study drug administration
Measured: From first dose of treatment through to 90 days after end of treatment
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of study drug will be assessed by summarizing the number of subjects who develop detectable ADAs.
Measured: From first dose of study drgu through to 90 days after end of treatment
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR), based on RECIST Version 1.1.
Measured: Up to 2 years
Disease control rate (DCR)
DCR is defined as the number (%) of subjects with best of response of confirmed CR or PR, or stable disease (SD) according to RECIST v1.1.
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.
- First posted20 Jan 2022
- Study start15 Mar 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Non Randomised
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex HL Wong, MMedSc, Study director, Akeso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200273
- Sponsor's protocol ID
- AK114-102
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05200273
- Acronym / sponsor ID
- AK114-102
- Conditions
- Advanced or Metastatic Solid Tumors, Malignancy, Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.
Detailed description
This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunogenicity in adult subjects with advanced or metastatic solid tumors. The study is comprised of dose escalation phase. Approximately 30 subjects will be treated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non Randomised
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Drug: AK114Experimental |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written and signed informed consent
- Age ≥ 18
- Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor
- Subject must have at least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1
Key exclusion criteria (10 listed)
- History of severe hypersensitivity reactions to other monoclonal antibodies
- History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events
- Patients with clinically significant cardiovascular disease
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of investigational product administration
- Active or prior documented autoimmune disease within the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK114AK114 administered by subcutaneous injection | Drug | Intervention/treatment |
Primary outcome
Incidence of adverse events (AEs)
Time frame: From the time of informed consent signed through to 90 days after last dose of study drug
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study drug, whether or not considered related to the study drug.
Number of participants with a Dose Limiting Toxicity (DLTs)
Time frame: Within the first 28 days after receiving the first dose of study drug
DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
4 secondary outcomes
Serum pharmacokinetics (PK)
Time frame: From first dose of treatment through to 90 days after end of treatment
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of study drgu through to 90 days after end of treatment
Objective response rate (ORR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex HL Wong, MMedSc study director
Akeso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK114 in people with Advanced or Metastatic Solid Tumors and Malignancy, run by Akeso at 1 site 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Jan 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex HL Wong, MMedSc (+86(0760)89873999, global.trials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: From the time of informed consent signed through to 90 days after 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?
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 20 Jan 2022.