New drug duo offers hope for advanced stomach cancer patients
NCT ID NCT04982276
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two experimental drugs, AK109 and AK104, with or without chemotherapy, for people with advanced stomach or gastroesophageal junction cancer that has not responded to first-line treatment. The goal is to see if the combination can shrink tumors or slow disease progression. About 138 adults aged 18 to 75 with good performance status are being recruited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written and signed informed consent 2. Age ≥ 18 years but ≤ 75 years 3. ECOG of 0 or 1. 4. Estimated life expectancy of ≥3 months. 5. Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma. 6. At least one measurable lesion per RECIST v1.1. 7. Gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma with failure of first-line treatment with anti-PD-1/L1 and chemotherapy 8. Adequate organ function. 9. Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration. Exclusion Criteria: 1. 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. 2. Any previous systemic therapy targeting VEGF or anti-VEGFR signaling pathways. 3. 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). 4. Known history of primary immunodeficiency virus infection. 5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 6. Known history of interstitial lung disease. 7. Known history of active tuberculosis (TB). 8. Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease. 9. 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. 10. Known history of testing positive for human immunodeficiency virus (HIV). 11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 12. 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. 13. Pregnant or lactating women.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Beijing Cancer Hospital
RECRUITINGBeijing, China
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