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ATG-022

Phase 1

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 14, 2026

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

Clinical trial landscape

ATG-022 · 1 trial · 1 indication

Phase 1 1
NCT07327229A 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 AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
RECRUITING132 Analytics
PHASE1RECRUITING
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
Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

AEs and SAEs
12 months after the last subject enrolled
DLT
Up to 21 Days

Dose Limiting Toxicity

RP2D
Up to 21 Days

RP2D= Recommended Phase 2 Dose

Secondary Endpoints

ORR
12 months after the last subject enrolled
DOR
12 months after the last subject enrolled
PFS
12 months after the last subject enrolled
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ATG-022+pembrolizumab/KEYTRUDA®EXPERIMENTAL -
ATG-022+pembrolizumab/KEYTRUDA®+CAPOXACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ATG-022DRUG1.8mg/kg Q3W, every 21 days as one cycle
pembrolizumab/KEYTRUDA®DRUG20mg Q3W, every 21 days as one cycle
CAPOXDRUGStandard 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. Aged ≥18 years as of the date of consent. 3. Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with ...

Countries:China
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Frequently asked questions about ATG-022

What is ATG-022 used for in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma?

ATG-022 is an investigational small molecule being studied for the treatment of unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma that is Claudin (CLDN) 18.2-positive and HER2-negative. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does ATG-022 target?

ATG-022 targets Claudin (CLDN) 18.2, a protein expressed on certain tumor cells. The drug is being evaluated in patients whose tumors are CLDN 18.2-positive and HER2-negative, indicating a biomarker-selected approach to treatment for gastric or gastroesophageal junction adenocarcinoma.

Who makes ATG-022?

ATG-022 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials and has not yet received regulatory approval.

What phase is ATG-022 in?

ATG-022 is in Phase 1 clinical development. It is being studied in an active Phase Ib/II trial, but the drug remains investigational and has not been approved by the FDA or other regulatory agencies for any use.

What clinical trials is ATG-022 in?

ATG-022 is being evaluated in a Phase Ib/II study with the identifier NCT07327229. This trial is recruiting participants in China and is studying ATG-022 in combination with pembrolizumab, with or without chemotherapy, in patients with CLDN 18.2-positive, HER2-negative unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Is ATG-022 the same as pembrolizumab?

No, ATG-022 is not the same as pembrolizumab. ATG-022 is a small molecule targeting CLDN 18.2, while pembrolizumab is a separate immunotherapy agent. In the ongoing clinical trial, ATG-022 is being studied in combination with pembrolizumab, with or without chemotherapy, for the treatment of gastric cancer.