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

April 10, 2026 updated by: Antengene Biologics Limited

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia
        • Completed
        • Cancer Research SA Pty Ltd
      • Malvern, Australia
      • South Brisbane, Australia
        • Recruiting
        • Integrated Clinical Oncology Network Pty Ltd (ICON)
        • Contact:
        • Principal Investigator:
          • Jermaine Coward
  • China
      • Beijing, China
        • Recruiting
        • Beijing GoBroad Hospital
        • Principal Investigator:
          • Ming Lu, MD
        • Contact:
      • Chengdu, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Principal Investigator:
          • Li Zheng, MD
        • Principal Investigator:
          • Dan Cao, MD
      • Fuzhou, China
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Rongbo Lin, MD
        • Principal Investigator:
          • Qin Xu, MD
      • Hefei, China
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Gang Wang, MD
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Principal Investigator:
          • Kangsheng Gu, MD
        • Contact:
      • Jinan, China
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Meili Sun, MD
        • Contact:
      • Lanzhou, China
        • Recruiting
        • Gansu provincial cancer hospital [recruiting]
        • Contact:
        • Principal Investigator:
          • Yuhua Liu, MD
      • Qingdao, China
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
        • Principal Investigator:
          • Jing Lv, MD
      • Shanghai, China
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Hongxia Wang, MD
      • Shanghai, China
        • Recruiting
        • Tongren Hospital Shanghai
        • Contact:
        • Principal Investigator:
          • Jianjun Zhang, MD
      • Shenyang, China
        • Recruiting
        • Liaoning Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jingdong Zhang, MD
      • Shijiangzhuang, China
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Principal Investigator:
          • Qun Zhao, MD
        • Contact:
      • Taiyuan, China
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jinfeng Ma, MD
      • Tianjin, China
        • Recruiting
        • Tianjin Medical Universuty Cancer Institute & Hospital
        • Principal Investigator:
          • Ting Deng, MD
        • Contact:
      • Wuhan, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xinjun Liang, MD
      • Xi'an, China
        • Recruiting
        • The First affiliated hospital of Xi'An Jiao Tong Ubiversity
        • Contact:
        • Principal Investigator:
          • Aili Suo, MD
      • Xuzhou, China
        • Recruiting
        • Xuzhou Central Hospital
        • Principal Investigator:
          • Yuan Yuan, MD
        • Contact:
      • Yinchuan, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Principal Investigator:
          • Ping Chen, MD
        • Contact:
      • Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhenghzou University
        • Principal Investigator:
          • Yanru Qin, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  9. Male subjects should be willing to use effective contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.

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.
  11. Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .
  12. In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocol compliance or may be unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATG-022

Dose Escalation Phase:

for subjects with solid tumors,approximately 16-36 subjects will be enrolled .

Dose Expansion Phase:

The tumor types in the Dose Expansion Phase may involve other tumor types based on the signals from the Dose Escalation Phase. The total number of patients in dose expansion will be up to approximately 120 patients.
Drug: ATG-022

Dose Escalation Phase:

A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg once every 3 weeks (Q3W) with 1 subject ,the following dose cohorts (0.9, 1.8, 2.4, 3.0, and 3.6 mg/kg Q3W) will require at least 3 and up to 6 evaluable subjects by using dose escalation plan of "3+3" design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: Up to 21 Days
Number of Participants with Dose Limiting Toxicity
Up to 21 Days
MTD
Time Frame: Up to 21 Days
Maximum Tolerated Dose
Up to 21 Days
RP2D
Time Frame: Up to 21 Days
RP2D= Recommended Phase 2 Dose
Up to 21 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 12 months after the last subject enrolled
Overall Response Rate
12 months after the last subject enrolled
DOR
Time Frame: 12 months after the last subject enrolled
Duration of Response
12 months after the last subject enrolled
PFS
Time Frame: 12 months after the last subject enrolled
Progression Free Survival
12 months after the last subject enrolled

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 12 months after the last subject enrolled
Overall Survival
12 months after the last subject enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antengene Biologics Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATG-022-ST-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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