Advanced or Metastatic Solid TumoursEarly Phase 1NCT05021120
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours
A Early Phase 1 study testing AK127 and AK104 in people with Advanced or Metastatic Solid Tumours, run by Akesobio Australia Pty Ltd at 5 sites in Australia.
Trial summary
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumours
- What is being tested?
- AK127 and AK104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 5 sitesAustralia
- Study dates
- 12 Oct 2021to 1 Apr 2025
- Phase
- Early 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
- In Phase 1a, patients with relapsed or refractory advanced solid malignancies
- In Phase 1b, patients must have received no more than three prior lines of systemic therapy
- 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 or fresh tumor tissue
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- Adequate organ function.
- For dose-expansion cohorts (Phase 1b), subjects must be willing to provide two fresh biopsy samples (pre-treatment and on treatment), where clinically appropriate.
- 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.
Who cannot join
- History of severe hypersensitivity reactions to other mAbs.
- Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
- Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
- Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment
- Any major surgery within 4 weeks prior to the first dose of treatment
- Receiving agents with immunomodulatory effect within 2 weeks prior to the first dose of treatment.
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- Active or prior documented inflammatory bowel disease
- History of organ transplant.
- History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies.
- Known active hepatitis B or C infections or history of HIV.
- Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
- Patients with severe heart and lung dysfunction.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Ashford Cancer Centre Research
Adelaide
Austin Health
Melbourne
Monash Health
Melbourne
Southside Cancer Care Centre
Sydney
The Kinghorn Cancer Centre, St Vincents Hospital Sydney
Sydney
About this study
Official title: A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.
Read the detailed description
This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor.
- Conditions
- Advanced or Metastatic Solid Tumours
- Being tested
- AK127, AK104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK127Drug
Subjects will receive AK127 by intravenous administration
AK104Drug
After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | Experimental Receives: Drug: AK127; Drug: AK104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 to 90 days after end of treatment
Number of participants with a Dose Limiting Toxicity (DLT)
DLTs will be assessed during the first treatment cycle and assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
Measured: Within the first six weeks of treatment
Secondary outcomes (8)
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 2 years
Disease control rate (DCR)
Progression-free survival is defined as the time from the start of treatment with AK127 + AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
Measured: Up to 2 years
Area under the curve (AUC) of AK127+AK104 for assessment of pharmacokinetics
The endpoints for assessment of PK including serum concentrations of AK127+AK104 at different timepoints after treatment administration.
Measured: From first dose of treatment through to 90 days after end of treatment
Maximum observed concentration (Cmax) of AK127 + AK104
The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment administration.
Measured: From first dose of treatment through to 90 days after end of treatment.
Minimum observed concentration (Cmin) of AK127+AK104
The endpoints for assessment of PK of AK127+AK104 include serum concentrations of AK127+AK104 at different timepoints after treatment 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 AK127+AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Measured: From first dose of treatment through to 90 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start12 Oct 2021
- Primary completion1 Oct 2024
- Study completion1 Apr 2025
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 TumoursStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akesobio Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021120
- Sponsor's protocol ID
- AK127-101
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumour Activity of AK127 in Combination With AK104 in Subjects With Advanced or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT05021120
- Acronym / sponsor ID
- AK127-101
- Conditions
- Advanced or Metastatic Solid Tumours
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Akesobio Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 25 Aug 2021 (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 AK127 in combination with AK104.
Detailed description
This is a , Phase 1, first-in-human, multicenter, open label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104 in subjects with advanced and metastatic solid tumours. The study comprises of 2 phases: a dose escalation phase and a dose expansion phase. Dose escalation for AK127 will occur using the 3+3+3 model given with a fixed regimen of AK104. Dose expansion will open at the discretion of the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Drug: AK127, Drug: AK104Experimental |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written and signed informed consent
- In Phase 1a, patients with relapsed or refractory advanced solid malignancies
- In Phase 1b, patients must have received no more than three prior lines of systemic therapy
- Subject must have at least one measurable lesion according to RECIST Version1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
Key exclusion criteria (12 listed)
- History of severe hypersensitivity reactions to other mAbs.
- Subjects with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily ) or other immunosuppressive medications within 2 weeks of study drug administration.
- Prior use of approved or investigational anti-TIGIT, anti-PVRIG, or anti-CD96 therapy
- Receiving any Other anticancer therapy (e.g., chemotherapy, radiotherapy, biologic or hormonal therapy for cancer treatment. etc.) within 4 weeks prior to the first dose of treatment
- Any major surgery within 4 weeks prior to the first dose of treatment
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 |
|---|---|---|
| AK127Subjects will receive AK127 by intravenous administration | Drug | Intervention/treatment |
| AK104After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration | Drug | Intervention/treatment |
Primary outcome
Incidence and Nature of Adverse Events (AEs)
Time frame: From the time of informed consent signed through to 90 days after end of treatment
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.
Number of participants with a Dose Limiting Toxicity (DLT)
Time frame: Within the first six weeks of treatment
DLTs will be assessed during the first treatment cycle and assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
8 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Area under the curve (AUC) of AK127+AK104 for assessment of pharmacokinetics
Time frame: From first dose of treatment through to 90 days after end of treatment
Maximum observed concentration (Cmax) of AK127 + AK104
Time frame: From first dose of treatment through to 90 days after end of treatment.
Minimum observed concentration (Cmin) of AK127+AK104
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 treatment through to 90 days after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AK127 and AK104 in people with Advanced or Metastatic Solid Tumours, run by Akesobio Australia Pty Ltd at 5 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 9 inclusion and 12 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 to 90 days after end of treatment). 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 4 Dec 2025.