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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntengene Biologics Limited

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.

Aged ≥18 years as of the date of consent.

Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression.

Archival tumor tissue sample within 36 months prior to participating in the study or newly obtained biopsy of a tumor lesion not previously irradiated should be provided for testing of CLDN 18.2 and PD-L1 expression for determining the criteria.

Disqualifiers

Known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.

Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE.

Prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (e.g., a period of 5 'halflives'), whichever is the most appropriate as judged by the investigator.

Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ATG-022

    Drug

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

  • pembrolizumab/KEYTRUDA®

    Drug

    20mg Q3W, every 21 days as one cycle

  • CAPOX

    Drug

    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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: ATG-022+pembrolizumab/KEYTRUDA®Experimental treatment 2 interventions
Group B: ATG-022+pembrolizumab/KEYTRUDA®+CAPOXActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

AEs and SAEs

Time frame
12 months after the last subject enrolled
2

DLT

Dose Limiting Toxicity

Time frame
Up to 21 Days
3

RP2D

RP2D= Recommended Phase 2 Dose

Time frame
Up to 21 Days

Secondary outcomes

1

ORR

Overall Response Rate

Time frame
12 months after the last subject enrolled
2

DOR

Duration of Response

Time frame
12 months after the last subject enrolled
3

PFS

Progression Free Survival

Time frame
12 months after the last subject enrolled
4

Plasma concentration of ATG-022 and derived PK paramete

To characterize the PK of ATG-022

Time frame
One year after last patient first dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Antengene Biologics Limited

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator