Solid Tumor, AdultPhase 1/2NCT05559541
Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing AK119 and AK104 in people with Solid Tumor, Adult, run by Akeso at 1 site in China.
Trial summary
This is a Phase Ib/II Study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 combined with AK104 in tumor patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- AK119 and AK104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 31 May 2024
- Phase
- Phase 1/2
- 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
- Subjects must sign the written informed consent form (ICF) voluntarily.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 to1.
- Life expectancy ≥12 weeks.
- Subjects must have histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies, or for which no effective standard therapy is available.
- Subjects must have evaluable lesions according to RECIST v1.1.
- Subjects must have adequate organ function.
- Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug.
Who cannot join
- Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
- Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
- Have exposed to other products targeting T cell costimulation or immune checkpoint pathway excepts for PD-1/PD-L1 inhibitor.
- Anticancer therapy (e.g., chemotherapy, radiotherapy, etc.) within 4 weeks prior to the first dose of investigational product; Anticancer small-molecule targeted agent (e.g., tyrosine kinase inhibitor) within 2 weeks prior to the first dose of investigational product.
- Subjects with spinal cord compression or active brain metastases, except for subjects with untreated and asymptomatic brain metastases or with stable brain metastases after treatment.
- Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
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- Subjects whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the study.
- Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
- Patients with clinically significant cardio-cerebrovascular or venous thromboembolic disease.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- History of interstitial lung disease or noninfectious pneumonitis.
- Major surgery or trauma within 4 weeks prior to first dose of investigational product. Unhealed wound, ulcer or fracture within 4 weeks prior to first dose of investigational product.
- 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.
- Previous history of severe hypersensitivity reactions to other monoclonal antibodies.
- Patients are pregnant or breastfeeding, or plan to breastfeed during the study.
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 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
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Insitute & Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Multicenter, Open-Label, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of AK119 Combined With AK104 in Patients With Advanced Solid Tumors
This is a Phase Ib/II Study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 combined with AK104 in tumor patients.
- Conditions
- Solid Tumor, Adult
- Being tested
- AK119, AK104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK119Drug
AK119 is an anti-CD73 monoclonal antibody.
AK104Drug
AK104 is an anti-PD-1 and CTLA-4 bispecific antibody.
| Study group | Role | What they receive |
|---|---|---|
| AK119+AK104 | Experimental | AK119 and AK104 IV every 2 or every 3 weeks. Receives: Drug: AK119; Drug: AK104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first 3 or 4 weeks of treatment. 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 3 or 4 weeks
Number of subjects with adverse events (AEs)
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, 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.
Objective response rate (ORR)
ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).
Measured: Up to 2 years
Secondary outcomes (7)
Progression-free survival (PFS)
PFS 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 (based on RECIST Version 1.1).
Measured: Up to 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).
Measured: Up to 2 years
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 (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Time to response (TTR)
Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).
Measured: Up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Measured: Up to 2 years
PK parameters
The PK parameters include serum concentrations of AK119 and AK104 at different timepoints after study drug administration.
Measured: From first dose of study drug through last dose
Immunogenicity assessment
The immunogenicity of AK119 and AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Measured: From first dose of study drug through 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start15 Dec 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihui Hao, PhD, Principal investigator, Tianjin Medical University Cancer Insitute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559541
- Sponsor's protocol ID
- AK119-104
- Status last verified
- Feb 2025
- First submitted
- 26 Sep 2022
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of AK119 Combined With AK104 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05559541
- Acronym / sponsor ID
- AK119-104
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development strategy adjustment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Sep 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.
This is a Phase Ib/II Study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 combined with AK104 in tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK119+AK104 | Experimental | Drug: AK119, Drug: AK104AK119 and AK104 IV every 2 or every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must sign the written informed consent form (ICF) voluntarily.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 to1.
- Life expectancy ≥12 weeks.
- Subjects must have histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies, or for which no effective standard therapy is available.
Key exclusion criteria (18 listed)
- Prior malignancy active within the previous 3 years except for the locally curable cancers that have been apparently cured.
- Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
- Have exposed to other products targeting T cell costimulation or immune checkpoint pathway excepts for PD-1/PD-L1 inhibitor.
- Anticancer therapy (e.g., chemotherapy, radiotherapy, etc.) within 4 weeks prior to the first dose of investigational product; Anticancer small-molecule targeted agent (e.g., tyrosine kinase inhibitor) within 2 weeks prior to the first dose of investigational product.
- Subjects with spinal cord compression or active brain metastases, except for subjects with untreated and asymptomatic brain metastases or with stable brain metastases after 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 |
|---|---|---|
| AK119AK119 is an anti-CD73 monoclonal antibody. | Drug | AK119+AK104 |
| AK104AK104 is an anti-PD-1 and CTLA-4 bispecific antibody. | Drug | AK119+AK104 |
Primary outcome
Number of subjects with dose limiting toxicities (DLTs)
Time frame: During the first 3 or 4 weeks
DLTs will be assessed during the first 3 or 4 weeks of treatment. 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.
Number of subjects with adverse events (AEs)
Time frame: From the time of informed consent signed through 90 days after the last dose of study drug.
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Objective response rate (ORR)
Time frame: Up to 2 years
ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).
7 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Time to response (TTR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
PK parameters
Time frame: From first dose of study drug through last dose
Immunogenicity assessment
Time frame: From first dose of study drug through 30 days after last dose
Results and safety
The study was stopped early (reason given: Development strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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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.
Jihui Hao, PhD principal investigator
Tianjin Medical University Cancer Insitute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AK119 and AK104 in people with Solid Tumor, Adult, run by Akeso at 1 site 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 18 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: stopped early, as of the sponsor's last update on 19 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 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Development strategy adjustment). Results are not available in the source record.
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 subjects with dose limiting toxicities (DLTs) (time frame: During the first 3 or 4 weeks). The study lists 3 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 19 Feb 2025.