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A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

NCT05718895•Antengene Biologics Limited

View on ClinicalTrials.gov

Summary

This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors

Detailed Description

This is a Phase I, multi-center, open-label, dose-finding study of ATG-022 in patients with advanced solid tumours. The study design includes a Dose Escalation Phase which will enroll subjects with advanced/metastatic solid tumors, and a Dose Expansion Phase which will enroll select advanced/metastatic solid tumors with Claudin 18.2-positive expression at the defined maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) to further evaluate the safety, tolerability, and efficacy of ATG-022.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
•2. Aged at least 18 years as of the date of consent.
•3. Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or not applicable for standard therapy(ies).
•1. Dose Escalation Phase: all solid tumors.
•2. Dose Expansion Phase: Claudin 18.2 positive solid tumors.
•4. Subjects should be willing to receive a biopsy at screening, if no former available tumor tissue samples within 36 months prior to participating in the study are provided.
•5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
•6. Estimated life expectancy of a minimum of 12 weeks.
•7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .
•8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding, and must have a negative pregnancy test prior to the start of dosing if of child-bearing potential or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening
+1 more criteria

Exclusion Criteria

•1. Primary central nervous system disease or central nervous system metastatic disease.
•2. Prior exposure to a Claudin 18.2 targeting agent.
•3. Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of 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 (eg, a period of 5 'half-lives'.
•4. Prior vaccination within 28 days of the first dose of study therapy.
•5. Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion \< 6 months prior to the first dose of study treatment.
•6. Active infection including hepatitis B, and/or hepatitis C.
•7. Known history of human immunodeficiency virus (HIV) infection.
•8. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.
•9. Pregnant or nursing females.
•10. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022.
+2 more criteria

Locations (16)

Cancer Research SA Pty Ltd

Adelaide, Australia

Cabrini Health Limited

Malvern, Australia

Integrated Clinical Oncology Network Pty Ltd (Icon)

South Brisbane, Australia

West China Hospital, Sichuan University

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Jinan Central Hospital

Jinan, China

Gansu provincial cancer hospital [recruiting]

Lanzhou, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tongren Hospital Shanghai

Shanghai, China

Key Dates

Start Date

March 27, 2023

Primary Completion Date

June 30, 2026

Completion Date

June 30, 2026

Last Updated

June 5, 2025

Enrollment

156

ESTIMATED participants

Conditions

Advanced/Metastatic Solid Tumors

Interventions

ATG-022

DRUG

Contacts

Edwin Hoe

CONTACT

61 497 390 477 edwin.hoe@antengene.com

Sunny He

CONTACT

sunny.he@antengene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

Inclusion Criteria

Exclusion Criteria

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors

HY-0102 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumours

Study of NMS-1116354 in Advanced/Metastatic Solid Tumors