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A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07327229 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-04-14

No results posted yet for this study

Summary

This is A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions

  • Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

ATG-022

1.8mg/kg Q3W, every 21 days as one cycle

DRUG

pembrolizumab/KEYTRUDA®

20mg Q3W, every 21 days as one cycle

DRUG

CAPOX

Standard Dose level for CAPOX: Capecitabine 1000 mg/m2 PO BID on Day 1-14, Oxaliplatin 130 mg/m2 IV on Day 1, Cycled every 21 days (3 weeks) for 8 cycles.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2027-09-30
Completion
2029-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327229 on ClinicalTrials.gov