A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting Phase 3 Interventional Study
Gastric and Gastroesophageal Junction Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
506 (estimated)
Sponsor
Akeso · Industry
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About This Trial

This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent 2. Age ≥ 18 years and ≤ 75 years 3. Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma. 4. Failed first-line treatment with PD-(L)1 monoclonal antibody…
Contacts

Ting Liu

+86(0760)8987 3999

clinicaltrials@akesobio.com

CONTACT