A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
NCT04982276 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 138
Last updated 2025-11-19
Summary
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
- Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Interventions
- DRUG
-
Subjects will receive AK104 and AK109 in combination with paclitaxel.
- BIOLOGICAL
-
AK104
Subjects will receive AK104 by intravenous administration.
- BIOLOGICAL
-
AK109
Subjects will receive AK109 by intravenous administration.
- DRUG
-
Subjects will receive AK109 in combination with paclitaxel.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Lin Shen, MD · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-23
- Primary Completion
- 2025-12-30
- Completion
- 2027-01-31
Countries
- China
Study Locations
More Related Trials
-
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
NCT07253896 ·Status: RECRUITING ·Phase: PHASE2
-
Low-dose Radiotherapy Combined With Chemotherapy and AK112 as Second-line Treatment in Patients With Advanced G/GEJ Cancer
NCT06791148 ·Status: RECRUITING ·Phase: PHASE2
-
Ivonescimab (AK112) Plus Paclitaxel as Second-line Therapy in Patients With Advanced G/GEJ Cancer
NCT06904300 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
NCT06341335 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors
NCT04207463 ·Status: UNKNOWN ·Phase: PHASE2
-
AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer
NCT06196697 ·Status: RECRUITING ·Phase: PHASE2
-
To Evaluate the Efficacy and Safety of Cadonilimab With SOX as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
NCT05948449 ·Status: UNKNOWN ·Phase: PHASE2
-
Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer
NCT05853172 ·Status: RECRUITING ·Phase: PHASE2
-
Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer
NCT06349967 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
PD-1 Antibody + XELOX in 1st Line Serum A-fetoprotein (AFP)-Elevated Gastric or Gastroesophageal Junction Adenocarcinoma
NCT04098796 ·Status: UNKNOWN ·Phase: PHASE2
-
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT05702229 ·Status: RECRUITING ·Phase: PHASE2
-
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
NCT01053390 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of QL1604 Plus Nab-paclitaxel Versus Paclitaxel in Subjects With Advanced Gastric Cancer.
NCT04435652 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer
NCT03286244 ·Status: UNKNOWN ·Phase: PHASE1
-
Clinical Study of Nab-paclitaxel Combined With Toripalimab in Local Advanced or Metastatic G/GEJ Carcinoma
NCT04443036 ·Status: UNKNOWN ·Phase: NA
-
TQB2450 Plus Anlotinib Combined With Chemotherapy in the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma
NCT04891900 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
NCT05960955 ·Status: RECRUITING ·Phase: PHASE2
-
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
NCT04047953 ·Status: RECRUITING ·Phase: NA
-
Docetaxel, 5-Fluorouracil and Oxaliplatin in Adenocarcinoma of the Stomach or Gastroesophageal Junction Patients
NCT00526110 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
BGB A317 in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Carcinoma
NCT03469557 ·Status: COMPLETED ·Phase: PHASE2
-
Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ
NCT06808971 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction
NCT05918419 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma
NCT06415669 ·Status: RECRUITING ·Phase: PHASE2
-
Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT07151209 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer
NCT03137004 ·Status: UNKNOWN ·Phase: PHASE2