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Trial Title:
ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma
NCT ID:
NCT06206733
Condition:
Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Capecitabine
Oxaliplatin
Tislelizumab
Conditions: Keywords:
CLDN 18.2
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
ASKB589
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
ASKB589
Description:
ASKB589 will be administered as a minimum 3-hour IV infusion
Arm group label:
Group A
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin will be administered as a minimum 2-hour IV infusion
Arm group label:
Group A
Arm group label:
Group B
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine will be administered orally twice daily (bid).
Arm group label:
Group A
Arm group label:
Group B
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab will be administered every 3 weeks Intravenous infusion on day 1 of each
cycle.
Arm group label:
Group A
Arm group label:
Group B
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo will be administered as a minimum 3-hour IV infusion
Arm group label:
Group B
Summary:
This study is a multicenter, randomized, double-blind, standard-of-care controlled phase
III clinical study conducted in China. The purpose of this study is to evaluate the
efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and
PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).
Detailed description:
This study is a multicenter, randomized, double-blind, standard-of-care controlled phase
III clinical study conducted in China. The purpose of this study is to evaluate the
efficacy of ASKB589 plus CAPOX and PD-1 inhibitor compared with placebo plus CAPOX and
PD-1 inhibitor (as first-line treatment) as measured by Progression Free Survival (PFS).
This study will also evaluate efficacy, physical function, safety, and tolerability of
ASKB589, as well as its effects on quality of life. Pharmacokinetics (PK) of ASKB589 and
the immunogenicity profile of ASKB589 will be evaluated as well.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of gastric and gastroesophageal junction
2. Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior
to randomization
3. Suitable for chemotherapy combined with PD-1 inhibitor
4. Not suitable for anti-HER2 therapy
5. Have at least one measurable lesion according to RECIST1.1 assessed by site
investigator within 28 days prior to randomization
6. CLDN 18.2 positive
Exclusion Criteria:
1. Patients with active central nervous system (CNS) metastases or suspected
carcinomatous meningitis
2. Participants have significant gastric bleeding
3. The presence of clinically uncontrollable third interspace fluid
4. Received anti-CLDN18.2 antibody at any time in the past
5. Suspected complete or partial obstruction of gastroesophageal access
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing cancer hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Shen Lin
Email:
doctorshenlin@sina.cn
Start date:
January 25, 2024
Completion date:
December 30, 2028
Lead sponsor:
Agency:
AskGene Pharma, Inc.
Agency class:
Industry
Collaborator:
Agency:
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
AskGene Pharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06206733
