A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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 .
Eligibility criteria
Qualifiers
Written and signed informed consent
Age ≥ 18 years but ≤ 75 years
ECOG of 0 or 1.
Estimated life expectancy of ≥3 months.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AK109
- paclitaxel
- paclitaxel
- AK104
Treatment groups
138 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov