Actively Recruiting
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Led by Akeso · Updated on 2025-11-19
138
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official 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...
- Signed informed consent
- Age between 18 and 75 years
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
- At least one measurable lesion per RECIST v1.1 criteria
- Disease progression after first-line anti-PD-1/L1 and chemotherapy treatment
- 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 skin, bladder, cervical, or breast cancers
- Prior systemic therapy targeting VEGF or VEGFR pathways
- Previous treatment with anti-CTLA-4 antibodies or other T cell co-stimulatory or checkpoint therapies besides PD-1/PD-L1
- History of primary immunodeficiency virus infection
- History of allogeneic organ or hematopoietic stem cell transplantation
- History of interstitial lung disease
- History of active tuberculosis
- Central nervous system metastases or related complications
- Untreated or active hepatitis B or hepatitis C infection with detectable virus
- Known HIV positive status
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Active or certain autoimmune diseases requiring systemic treatment
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
T
Ting Liu, MD
CONTACT
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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