Advanced Malignant TumorsPhase 1/2NCT05214482
A Study of AK112 in Advanced Malignant Tumors
A Phase 1/2 study testing AK112, AK117 and Chemotherapy in people with Advanced Malignant Tumors, run by Akeso at 1 site in China.
Trial summary
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- AK112, AK117 and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2022to 31 Dec 2025
- 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
- 18 to 75 years old.
- Have a life expectancy of at least 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Phase Ib:Histologically or cytologically confirmed advanced solid tumor.
- Phase II:
- cohort 1 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma.
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- cohort 2 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic Biliary Tract Cancers, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer.
- cohort 3 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic pancreatic ductal adenocarcinoma.
- cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;Have previously received EGFR-TKI treatment and have progressed on or following.
- Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
- Has adequate organ function.
Who cannot join
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- Active central nervous system (CNS) metastases.
- History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
- Active Hepatitis B or Hepatitis C.
- Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
- History of severe bleeding tendency or coagulation disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/II Study of AK112（PD-1 / VEGF Bispecific Antibody） in Combination With AK117（Anti-CD47 Antibody）With or Without Chemotherapy in Advanced Malignant Tumors
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors
- Conditions
- Advanced Malignant Tumors
- Being tested
- AK112, AK117, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
IV infusion,Specified dose on specified days
AK117Drug
IV infusion,Specified dose on specified days
ChemotherapyDrug
IV infusion,Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib | Experimental | Subjects receive AK112 plus AK117 until progression Receives: Drug: AK112; Drug: AK117 |
| Phase II | Experimental | AK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy; Receives: Drug: AK112; Drug: AK117; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Events (AEs)
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Secondary outcomes (5)
Disease control rate (DCR)
Measured: Up to approximately 2 years
Duration of Response (DOR)
Measured: Up to approximately 2 years
Time to response (TTR)
Measured: Up to approximately 2 years
Progression free survival (PFS)
Measured: Up to approximately 2 years
Overall survival (OS)
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 posted28 Jan 2022
- Study start22 Jan 2022
- Primary completion20 Nov 2025
- Study completion31 Dec 2025
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 Advanced Malignant 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jieer Ying, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214482
- Sponsor's protocol ID
- AK117-202
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2022
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu Q, Zhou S, Zhang C, Zhou Y, He Y, Jiang Y, Li J, Yi T, Luo C, Zhang L, Wu J, Zhang Y, Wu M, Wei Q, Li Q, Liu B, Chen X, Yao Y, Yu C, Li J, Ren Y, Zhuo W, Yuan L, Li W, Wang ZM, Li B, Xia M, Xie Y, Wu K, Ying J. Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial. J Hepatol. 2026 Jul 6:S0168-8278(26)02682-6. doi: 10.1016/j.jhep.2026.06.033. Online ahead of print.
PubMed 42409321
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of AK112（PD-1 / VEGF Bispecific Antibody） in Combination With AK117（Anti-CD47 Antibody）With or Without Chemotherapy in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05214482
- Acronym / sponsor ID
- AK117-202
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 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.
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ib | Experimental | Drug: AK112, Drug: AK117Subjects receive AK112 plus AK117 until progression |
| Phase II | Experimental | Drug: AK112, Drug: AK117, Drug: ChemotherapyAK112 + chemotherapy± AK117 until progression; AK117 + chemotherapy; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 75 years old.
- Have a life expectancy of at least 3 months.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Phase Ib:Histologically or cytologically confirmed advanced solid tumor.
- Phase II:
Key exclusion criteria (6 listed)
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- Active central nervous system (CNS) metastases.
- History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
- Active Hepatitis B or Hepatitis C.
- Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
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 |
|---|---|---|
| AK112IV infusion,Specified dose on specified days | Drug | Phase II, Phase Ib |
| AK117IV infusion,Specified dose on specified days | Drug | Phase II, Phase Ib |
| ChemotherapyIV infusion,Specified dose on specified days | Drug | Phase II |
Primary outcome
Number of patients with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
5 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 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 3 Mar 2026.
- Derived from this study: PubMed 42409321Xu Q, Zhou S, Zhang C, Zhou Y, He Y, Jiang Y, Li J, Yi T, Luo C, Zhang L, Wu J, Zhang Y, Wu M, Wei Q, Li Q, Liu B, Chen X, Yao Y, Yu C, Li J, Ren Y, Zhuo W, Yuan L, Li W, Wang ZM, Li B, Xia M, Xie Y, Wu K, Ying J. Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial. J Hepatol. 2026 Jul 6:S0168-8278(26)02682-6. doi: 10.1016/j.jhep.2026.06.033. Online ahead of print.
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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.
Jieer Ying, MD principal investigator
Zhejiang Cancer 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 AK112, AK117 and Chemotherapy in people with Advanced Malignant Tumors, 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 11 inclusion and 6 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 3 Mar 2026. 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 patients with Adverse Events (AEs) (time frame: Up to approximately 2 years). 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 NCT05214482, 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 3 Mar 2026.