Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05718895

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

Led by Antengene Biologics Limited · Updated on 2026-04-15

156

Participants Needed

22

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent before any study procedures
  • Age 18 years or older
  • Confirmed solid tumor that has progressed despite or is intolerant to standard therapy, or standard therapy not applicable
  • Dose Escalation Phase: any solid tumor
  • Dose Expansion Phase: Claudin 18.2-positive solid tumors
  • Willing to have a biopsy at screening if no tumor tissue sample from the past 36 months is available
  • At least one measurable tumor lesion according to RECIST v1.1
  • Estimated life expectancy of at least 12 weeks
  • ECOG performance status of 0 or 1
  • Females of childbearing potential must use adequate contraception until 180 days after treatment ends, not be breastfeeding, and have a negative pregnancy test before dosing
  • Males must agree to use effective contraception during the study and for 180 days after the last dose
Not Eligible

You will not qualify if you...

  • Primary central nervous system disease or CNS metastases
  • Prior treatment with a Claudin 18.2 targeting agent
  • Chemotherapy, immunotherapy, or investigational cancer treatments within 28 days before the first study dose or still present in the body
  • Vaccination within 28 days before the first dose
  • Any solid organ transplant; autologous stem cell transplant or CAR-T cell therapy within 6 months before the first dose
  • Active infections including hepatitis B or C
  • Known HIV infection
  • Any unresolved side effects from prior treatments greater than Grade 1 except alopecia
  • Pregnant or nursing females
  • History of allergic reactions to drugs similar to ATG-022
  • Other primary cancers developed within 5 years except those cured locally
  • Conditions that may affect study compliance or suitability as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Cancer Research SA Pty Ltd

Adelaide, Australia

Completed

2

Cabrini Health Limited

Malvern, Australia

Actively Recruiting

3

Integrated Clinical Oncology Network Pty Ltd (Icon)

South Brisbane, Australia

Actively Recruiting

4

Beijing GoBroad Hospital

Beijing, China

Actively Recruiting

5

West China Hospital, Sichuan University

Chengdu, China

Actively Recruiting

6

Fujian Cancer Hospital

Fuzhou, China

Actively Recruiting

7

Anhui Provincial Hospital

Hefei, China

Actively Recruiting

8

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Actively Recruiting

9

Jinan Central Hospital

Jinan, China

Actively Recruiting

10

Gansu provincial cancer hospital [recruiting]

Lanzhou, China

Actively Recruiting

11

The Affiliated Hospital of Qingdao University

Qingdao, China

Actively Recruiting

12

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

13

Tongren Hospital Shanghai

Shanghai, China

Actively Recruiting

14

Liaoning Cancer Hospital

Shenyang, China

Actively Recruiting

15

The Fourth Hospital of Hebei Medical University

Shijiangzhuang, China

Actively Recruiting

16

Shanxi provincial cancer hospital

Taiyuan, China

Actively Recruiting

17

Tianjin Medical Universuty Cancer Institute & Hospital

Tianjin, China

Actively Recruiting

18

Hubei Cancer Hospital

Wuhan, China

Actively Recruiting

19

The First affiliated hospital of Xi'An Jiao Tong Ubiversity

Xi'an, China

Actively Recruiting

20

Xuzhou Central Hospital

Xuzhou, China

Actively Recruiting

21

General Hospital of Ningxia Medical University

Yinchuan, China

Actively Recruiting

22

The First Affiliated Hospital of Zhenghzou University

Zhengzhou, China

Actively Recruiting

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Research Team

F

Felix Li

CONTACT

S

Sunny He

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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