Solid Tumor, AdultPhase 1/2NCT04597541
A Study of AK112 for Advanced Solid Tumors
A Phase 1/2 study testing AK112 in people with Solid Tumor, Adult, run by Akeso at 1 site in China.
Trial summary
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. This trial is a two parts, phase I/II study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- AK112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2020to 15 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years old (at the time consent is obtained);
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
- Have histologically- or cytologically-confirmed diagnosis of advanced solid tumor;
- Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy;
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
- Subject must have at least one measurable lesion according to RECIST Version1.1;
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- Adequate organ function;
- Females of childbearing potential and non-sterilized males who are sexually active must use an effective method;
- Adequate life expectancy.
Who cannot join
- History of severe hypersensitivity reactions to other mAbs;
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria;
- Major surgical procedure within 30 days prior to the first dose of AK112 or still recovering from prior surgery;
- Receipt of any immunotherapy, any conventional or investigational systemic anticancer therapy within 4 weeks prior to the first dose of AK112 except for treatment with small-molecule tyrosine kinase-targeted agents within 2 weeks prior to the first dose of AK112;
- History of primary immunodeficiency;
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis);
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- History of organ transplant or hematopoietic stem cell that requires use of immunosuppressives;
- Known allergy or reaction to any component of the AK112 formulation;
- History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies;
- Known history of tuberculosis;
- Known history of HIV;
- Receipt of live attenuated vaccination within 30 days prior to the first dose of AK112;
- Any condition 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.
About this study
Official title: A Phase I/II Trial of AK112 in Advanced Solid Tumor
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. This trial is a two parts, phase I/II study. All patients are advanced solid tumor, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Part one is dose escalation phase,part two is dose expansion phase. The primary end point is safety. Secondary end points are objective response rate,progression-free survival and overall survival per RECIST1.1.
- Conditions
- Solid Tumor, Adult
- Being tested
- AK112
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
AK112 is a PD1/VEGF bispecific antibody;AK112 is given by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AK112 Receives: Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 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 time ICF is signed until 90 days after last dose of AK112
Number of participants with DLTs
DLTs will be assessed during the first 4 weeks 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 (4 weeks) of treatment.
Measured: During the first four weeks of treatment
Secondary outcomes (4)
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)
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD at 16 and 24 weeks respectively) based on RECIST Version 1.1.
Measured: Up to 2 years
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with AK112 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 with AK112 until death due to any cause.
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 posted22 Oct 2020
- Study start21 Oct 2020
- Primary completion31 Mar 2022
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597541
- Sponsor's protocol ID
- AK112-102
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2020
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang F, Wei X, Zheng Y, Wang J, Ying J, Chen X, Luo S, Luo H, Yu X, Chen B, Ma L, Xu R. Safety, Pharmacokinetics, and Pharmacodynamics Evaluation of Ivonescimab, a Novel Bispecific Antibody Targeting PD-1 and VEGF, in Chinese Patients With Advanced Solid Tumors. Cancer Med. 2025 Mar;14(6):e70653. doi: 10.1002/cam4.70653.
PubMed 40114411
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of AK112 in Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04597541
- Acronym / sponsor ID
- AK112-102
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 22 Oct 2020 (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 study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. This trial is a two parts, phase I/II study. All patients are advanced solid tumor, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Part one is dose escalation phase,part two is dose expansion phase. The primary end point is safety. Secondary end points are objective response rate,progression-free survival and overall survival per RECIST1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AK112AK112 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 to 75 years old (at the time consent is obtained);
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
- Have histologically- or cytologically-confirmed diagnosis of advanced solid tumor;
- Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy;
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
Key exclusion criteria (13 listed)
- History of severe hypersensitivity reactions to other mAbs;
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria;
- Major surgical procedure within 30 days prior to the first dose of AK112 or still recovering from prior surgery;
- Receipt of any immunotherapy, any conventional or investigational systemic anticancer therapy within 4 weeks prior to the first dose of AK112 except for treatment with small-molecule tyrosine kinase-targeted agents within 2 weeks prior to the first dose of AK112;
- History of primary immunodeficiency;
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 |
|---|---|---|
| AK112AK112 is a PD1/VEGF bispecific antibody;AK112 is given by intravenous infusion. | Drug | 1 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: From time ICF is signed until 90 days after last dose of AK112
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 DLTs
Time frame: During the first four weeks of treatment
DLTs will be assessed during the first 4 weeks 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 (4 weeks) of treatment.
4 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
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 10 Mar 2025.
- Derived from this study: PubMed 40114411Wang F, Wei X, Zheng Y, Wang J, Ying J, Chen X, Luo S, Luo H, Yu X, Chen B, Ma L, Xu R. Safety, Pharmacokinetics, and Pharmacodynamics Evaluation of Ivonescimab, a Novel Bispecific Antibody Targeting PD-1 and VEGF, in Chinese Patients With Advanced Solid Tumors. Cancer Med. 2025 Mar;14(6):e70653. doi: 10.1002/cam4.70653.
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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.
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 AK112 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 9 inclusion and 13 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 10 Mar 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 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?
Number of participants with adverse events (AEs) (time frame: From time ICF is signed until 90 days after last dose of AK112). 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 NCT04597541, which also lists 1 linked publication.
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 10 Mar 2025.