Solid TumorPhase 1NCT06166888
A Study of AK131 in Patients With Advanced Solid Tumors
A Phase 1 study testing AK131 in people with Solid Tumor, run by Akeso at 1 site in China.
Trial summary
This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- AK131
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Life expectancy ≥3 months.
- Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- Subject must have at least one measurable lesion according to RECIST Version1.1.
- 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
- Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers.
- Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
- Receipt of any anti-CD73 treatment.
- Anticancer therapy within 4 weeks prior to the first dose of investigational product.
- Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- 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.
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- Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 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.
- Patients with clinically significant cardio-cerebrovascular disease.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- History of interstitial lung disease or noninfectious pneumonitis.
- Major surgery, trauma,unhealed wound, ulcer or fracture within 4 weeks prior to first dose of investigational product.
- Any condition that required systemic treatment with corticosteroids 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.
- Known allergy or reaction to any component of the AK131 formulation.
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinming Yu
Jinan, Shandong, 250117
Jinming Yu, PhD, 13806406293, sdyujinming@126.com
About this study
Official title: A Phase Ia/Ib, Multicenter and Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Anti-PD-1 and CD73 Bispecific Antibody AK131 in Patients With Advanced Solid Tumors
This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients
- Conditions
- Solid Tumor
- Being tested
- AK131
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK131Drug
AK131 is an anti-PD-1 and CD73 bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| AK131 | Experimental | Subjects will receive AK131 via intravenously (IV) Q2W or Q3W, up to 2 years Receives: Drug: AK131 |
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 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 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
Secondary outcomes (8)
Serum PK concentration of AK131
Serum PK concentration of AK131 in individual subjects at different time points after AK131 administration
Measured: From first dose of study drug through 30 days after last dose of study drug
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK131 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: From first dose of study drug through 30 days after last dose of study drug
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR (based on RECIST Version 1.1).
Measured: Up to approximately 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 approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Time to response (TTR)
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 approximately 2 years
Duration of Response (DoR)
DoR 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 approximately 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start10 Jan 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166888
- Sponsor's protocol ID
- AK131-101
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2023
- Last updated
- 17 Jan 2024
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib, Multicenter and Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Anti-PD-1 and CD73 Bispecific Antibody AK131 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06166888
- Acronym / sponsor ID
- AK131-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Dec 2023 (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 Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK131 | Experimental | Drug: AK131Subjects will receive AK131 via intravenously (IV) Q2W or Q3W, up to 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written and signed informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
- Life expectancy ≥3 months.
- Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- Subject must have at least one measurable lesion according to RECIST Version1.1.
Key exclusion criteria (18 listed)
- Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers.
- Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
- Receipt of any anti-CD73 treatment.
- Anticancer therapy within 4 weeks prior to the first dose of investigational product.
- Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
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 |
|---|---|---|
| AK131AK131 is an anti-PD-1 and CD73 bispecific antibody | Drug | AK131 |
Primary outcome
Number of subjects with dose limiting toxicities (DLTs)
Time frame: During the first 4 weeks
DLTs will be assessed during the first 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.
8 secondary outcomes
Serum PK concentration of AK131
Time frame: From first dose of study drug through 30 days after last dose of study drug
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of study drug through 30 days after last dose of study drug
Objective response rate (ORR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- 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.
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 AK131 in people with Solid Tumor, 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 7 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: looking for participants now, as of the sponsor's last update on 17 Jan 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Liu, MD (+86(0760)8987 3999, clinicaltrials@akesobio.com), or a site near the patient. 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 4 weeks). 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 17 Jan 2024.