Advanced Malignant TumorsPhase 1/2NCT05235542
A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors
A Phase 1/2 study testing AK104, AK117 and Capecitabine tablets 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 AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined 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?
- AK104, AK117 and Capecitabine tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2022to 9 May 2026
- 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 an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
- Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
- 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 AK104#PD-1 / CTLA-4 Bispecific Antibody# and AK117#Anti-CD47 Antibody# in Combination With or Without Chemotherapy in Advanced Malignant Tumors
Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors
- Conditions
- Advanced Malignant Tumors
- Being tested
- AK104, AK117, Capecitabine tablets, Oxaliplatin, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
IV infusion,Specified dose on specified days
AK117Drug
IV infusion,Specified dose on specified days
Capecitabine tabletsDrug
Oral,Specified dose on specified days
OxaliplatinDrug
IV infusion,Specified dose on specified days
CisplatinDrug
IV infusion,Specified dose on specified days
PaclitaxelDrug
IV infusion,Specified dose on specified days
IrinotecanDrug
IV infusion,Specified dose on specified days
DocetaxelDrug
IV infusion,Specified dose on specified days
5-FUDrug
IV infusion,Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib#Dosage regimen 1# | Experimental | Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression Receives: Drug: AK104; Drug: AK117 |
| Phase Ib#Dosage regimen 2# | Experimental | Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression Receives: Drug: AK104; Drug: AK117 |
| Phase II#Cohort 1# | Experimental | Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression Receives: Drug: AK104; Drug: AK117; Drug: Capecitabine tablets; Drug: Oxaliplatin |
| Phase II#Cohort 2# | Experimental | Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression Receives: Drug: AK104; Drug: AK117; Drug: Cisplatin; Drug: Paclitaxel; Drug: 5-FU |
| Phase II#Cohort 3# | Experimental | Gastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression Receives: Drug: AK117; Drug: Paclitaxel; Drug: Irinotecan; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Adverse Events (AEs)
Measured: Up to approximately 2 years
Objective Response Rate (ORR)
Measured: Up to approximately 2 years
Secondary outcomes (8)
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
Maximum observed concentration (Cmax) of AK117 and AK104
The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.
Measured: From first dose of study drug to last dose of of study drug
Minimum observed concentration (Cmin) of AK117 and AK104 at steady state
The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.
Measured: From first dose of study drug to last dose of of study drug
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK117 and AK104 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start12 Mar 2022
- Primary completion9 May 2026
- Study completion9 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liwei Wang, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235542
- Sponsor's protocol ID
- AK117-204
- Status last verified
- Jun 2026
- First submitted
- 25 Jan 2022
- Last updated
- 11 Jun 2026
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of AK104#PD-1 / CTLA-4 Bispecific Antibody# and AK117#Anti-CD47 Antibody# in Combination With or Without Chemotherapy in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05235542
- Acronym / sponsor ID
- AK117-204
- Conditions
- Advanced Malignant Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 9 May 2026 (actual)
- Study completion
- 9 May 2026 (actual)
- First posted
- 11 Feb 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 AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase Ib#Dosage regimen 1# | Experimental | Drug: AK104, Drug: AK117Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression |
| Phase Ib#Dosage regimen 2# | Experimental | Drug: AK104, Drug: AK117Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression |
| Phase II#Cohort 1# | Experimental | Drug: AK104, Drug: AK117, Drug: Capecitabine tablets, Drug: OxaliplatinGastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression |
| Phase II#Cohort 2# | Experimental | Drug: AK104, Drug: AK117, Drug: Cisplatin, Drug: Paclitaxel, Drug: 5-FUEsophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression |
| Phase II#Cohort 3# | Experimental | Drug: AK117, Drug: Paclitaxel, Drug: Irinotecan, Drug: DocetaxelGastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years old.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have a life expectancy of at least 3 months.
- Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
- Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
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 |
|---|---|---|
| AK104IV infusion,Specified dose on specified days | Drug | Phase II#Cohort 1#, Phase II#Cohort 2#, Phase Ib#Dosage regimen 1#, Phase Ib#Dosage regimen 2# |
| AK117IV infusion,Specified dose on specified days | Drug | Phase II#Cohort 1#, Phase II#Cohort 2#, Phase II#Cohort 3#, Phase Ib#Dosage regimen 1#, Phase Ib#Dosage regimen 2# |
| Capecitabine tabletsOral,Specified dose on specified days | Drug | Phase II#Cohort 1# |
| OxaliplatinIV infusion,Specified dose on specified days | Drug | Phase II#Cohort 1# |
| CisplatinIV infusion,Specified dose on specified days | Drug | Phase II#Cohort 2# |
| PaclitaxelIV infusion,Specified dose on specified days | Drug | Phase II#Cohort 2#, Phase II#Cohort 3# |
| IrinotecanIV infusion,Specified dose on specified days | Drug | Phase II#Cohort 3# |
| DocetaxelIV infusion,Specified dose on specified days | Drug | Phase II#Cohort 3# |
| 5-FUIV infusion,Specified dose on specified days | Drug | Phase II#Cohort 2# |
Primary outcome
Number of patients with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
8 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
Maximum observed concentration (Cmax) of AK117 and AK104
Time frame: From first dose of study drug to last dose of of study drug
Minimum observed concentration (Cmin) of AK117 and AK104 at steady state
Time frame: From first dose of study drug to last dose of 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
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 11 Jun 2026.
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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.
Liwei Wang, MD principal investigator
RenJi 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 AK104, AK117 and Capecitabine tablets 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 7 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 11 Jun 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?
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 11 Jun 2026.