Gastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaPhase 1/2NCT04982276
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
A Phase 1/2 study testing AK109, paclitaxel and AK104 in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Akeso at 1 site in China.
Trial summary
This is a multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- AK109, paclitaxel and AK104
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2021to 31 Jan 2027
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written and signed informed consent
- Age ≥ 18 years but ≤ 75 years
- ECOG of 0 or 1.
- Estimated life expectancy of ≥3 months.
- Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
- At least one measurable lesion per RECIST v1.1.
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- Gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma with failure of first-line treatment with anti-PD-1/L1 and chemotherapy
- Adequate organ function.
- Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
Who cannot join
- Other invasive malignancies within 3 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
- Any previous systemic therapy targeting VEGF or anti-VEGFR signaling pathways.
- In addition to PD1 or PD-L1,Prior exposure to anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
- Known history of primary immunodeficiency virus infection.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of interstitial lung disease.
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- Known history of active tuberculosis (TB).
- Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
- Patients with untreated chronic hepatitis B or HBV DNA exceeding 500IU/mL or active hepatitis C should be excluded. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.
- Known history of testing positive for human immunodeficiency virus (HIV).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
This is a multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .
- Being tested
- AK109, paclitaxel, AK104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK109Biological
Subjects will receive AK109 by intravenous administration.
paclitaxelDrug
Subjects will receive AK109 in combination with paclitaxel.
paclitaxelDrug
Subjects will receive AK104 and AK109 in combination with paclitaxel.
AK104Biological
Subjects will receive AK104 by intravenous administration.
| Study group | Role | What they receive |
|---|---|---|
| AK109 combined with chemotherapy | Experimental | AK109 combined with paclitaxel, iv, every 3 weeks Receives: Biological: AK109; Drug: paclitaxel |
| AK104 and AK109 combined with chemotherapy | Experimental | AK104 combined with AK109 and paclitaxel, iv, every 3 weeks Receives: Biological: AK109; Drug: paclitaxel; Biological: AK104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing dose-limiting toxicities (DLTs)
DLTs will be assessed during the first 28 days of treatment 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 .
Measured: During the first 4 weeks
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: up to 2 years
Objective response rate (ORR)
The 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 (6)
Progression-free survival (PFS)
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) or death from any cause (whichever occurs first)
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 v1.1
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 or death due to any cause, whichever occurs first.
Measured: Up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: up to 2 years
Observed pharmacokinetics (PK) exposure of AK109 and AK104
The endpoints for assessment of PK of AK109 and AK104 include serum concentrations of AK109 and AK104 at different timepoints after AK109 and AK104 administration.
Measured: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 and AK109 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)
Measured: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start23 Aug 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982276
- Sponsor's protocol ID
- AK109-201
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2021
- Last updated
- 19 Nov 2025
- Results posted
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04982276
- Acronym / sponsor ID
- AK109-201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Jul 2021 (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 multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK109 combined with chemotherapy | Experimental | Biological: AK109, Drug: paclitaxelAK109 combined with paclitaxel, iv, every 3 weeks |
| AK104 and AK109 combined with chemotherapy | Experimental | Biological: AK109, Drug: paclitaxel, Biological: AK104AK104 combined with AK109 and paclitaxel, iv, every 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written and signed informed consent
- Age ≥ 18 years but ≤ 75 years
- ECOG of 0 or 1.
- Estimated life expectancy of ≥3 months.
- Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
Key exclusion criteria (13 listed)
- Other invasive malignancies within 3 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
- Any previous systemic therapy targeting VEGF or anti-VEGFR signaling pathways.
- In addition to PD1 or PD-L1,Prior exposure to anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
- Known history of primary immunodeficiency virus infection.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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 |
|---|---|---|
| AK109Subjects will receive AK109 by intravenous administration. | Biological | AK104 and AK109 combined with chemotherapy, AK109 combined with chemotherapy |
| paclitaxelSubjects will receive AK109 in combination with paclitaxel. | Drug | AK109 combined with chemotherapy |
| paclitaxelSubjects will receive AK104 and AK109 in combination with paclitaxel. | Drug | AK104 and AK109 combined with chemotherapy |
| AK104Subjects will receive AK104 by intravenous administration. | Biological | AK104 and AK109 combined with chemotherapy |
Primary outcome
Number of subjects experiencing dose-limiting toxicities (DLTs)
Time frame: During the first 4 weeks
DLTs will be assessed during the first 28 days of treatment 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 .
Adverse events (AEs)
Time frame: up to 2 years
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.
Objective response rate (ORR)
Time frame: up to 2 years
The ORR is defined as the proportion of subjects with CR or PR, based on RECIST Version 1.1.
6 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
Overall survival (OS)
Time frame: up to 2 years
Observed pharmacokinetics (PK) exposure of AK109 and AK104
Time frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104
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 19 Nov 2025.
- 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.
Lin Shen, MD principal investigator
Peking University Cancer Hospital & Institute
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 AK109, paclitaxel and AK104 in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, 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: looking for participants now, as of the sponsor's last update on 19 Nov 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?
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 experiencing dose-limiting toxicities (DLTs) (time frame: During the first 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 Nov 2025.