Actively Recruiting
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
Led by Akeso · Updated on 2025-11-19
138
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of AK109 and AK104, alone or combined with chemotherapy, for treating advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has progressed after first-line treatment. This multicenter clinical study is a Phase Ib/II trial focusing on the safety and effectiveness of these therapies in this patient group. Participants will receive either AK109 plus paclitaxel chemotherapy or AK104 combined with AK109 and paclitaxel. All treatments are given intravenously every three weeks. The study compares these combinations to assess their impact on cancer control and tolerability. Throughout the study, participants will be monitored for dose-limiting toxicities during the first 4 weeks and adverse events for up to 2 years. Researchers will measure tumor response, progression-free survival, overall survival, and drug pharmacokinetics. The study lasts up to two years, with regular assessments, including imaging and laboratory tests, to evaluate the participants' health and treatment effects.
CONDITIONS
Brief Title
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written and signed informed consent
- Age 18 years or older but 75 years or younger
- ECOG performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- At least one measurable lesion according to RECIST v1.1 criteria
- Failure of first-line treatment with anti-PD-1/L1 and chemotherapy
- Adequate organ function
- Agreement to use effective contraception from consent until 120 days after last treatment
You will not qualify if you...
- Other invasive cancers within the last 3 years, except certain treated or cured types like basal or squamous skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ
- Previous systemic therapy targeting VEGF or anti-VEGFR pathways
- Prior exposure to anti-CTLA-4 antibody or other T cell co-stimulatory or checkpoint therapies besides PD1 or PD-L1
- History of primary immunodeficiency virus infection
- History of allogeneic organ or hematopoietic stem cell transplantation
- Known interstitial lung disease
- Active tuberculosis infection
- Central nervous system metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease
- Untreated or active hepatitis B or high HBV DNA levels; patients with positive HCV antibody are eligible if HCV RNA test is negative
- Known HIV infection
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Active or suspected autoimmune disease except for certain mild or stable conditions
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive AK109 alone or in combination with AK104 and paclitaxel by intravenous administration every 3 weeks as a second-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma.
Infusions every 3 weeks
Duration - Up to 2 years
Participants are monitored for adverse events, disease progression, and survival after completion of treatment.
Periodic visits during follow-up phase
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
T
Ting Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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