Trials / Recruiting
RecruitingNCT07327229
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
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- Antengene Biologics Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This is a phase Ib/II Study of ATG-022 plus pembrolizumab with/without chemotherapy in participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1), unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Both the intervention of ATG022 + Pembrolizumab (A+P) and the intervention of ATG-022 + pembrolizumab + chemotherapy (CAPOX regimen, A+P+C) consist of a Ib and II phase. Participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and having progressed on or after at least one prior systemic therapy, will be enrolled in the intervention of A + P. Participants with CLDN 18.2-positive, HER2-negative, PD-L1 positive (CPS≥1) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma and having not received any prior systemic therapy, will be enrolled in the intervention of A + P + C. The study will be firstly initiated from Ib of the intervention of A+P. The initiation of the intervention of A+P+C will be based on the clinical data of A+P
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-02-27
- Primary completion
- 2027-09-30
- Completion
- 2029-04-30
- First posted
- 2026-01-08
- Last updated
- 2026-04-14
Locations
30 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07327229. Inclusion in this directory is not an endorsement.