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Clinical Trials in China / NCT05718895
Recruiting Phase 1

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

NCT05718895 · tracked via the Priya Life Science China tracker
Sponsor
Antengene Biologics Limited
Phase
Phase 1
Started
2023-03-27
Last updated
2026-04-15

Condition(s) studied

Advanced/Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

ATG-022

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Cancer Research SA Pty Ltd Adelaide Australia Completed
Cabrini Health Limited Malvern Australia Recruiting
Integrated Clinical Oncology Network Pty Ltd (Icon) South Brisbane Australia Recruiting
Beijing GoBroad Hospital Beijing China Recruiting
West China Hospital, Sichuan University Chengdu China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Anhui Provincial Hospital Hefei China Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei China Recruiting
Jinan Central Hospital Jinan China Recruiting
Gansu provincial cancer hospital [recruiting] Lanzhou China Recruiting
The Affiliated Hospital of Qingdao University Qingdao China Recruiting
Fudan University Shanghai Cancer Center Shanghai China Recruiting
Tongren Hospital Shanghai Shanghai China Recruiting
Liaoning Cancer Hospital Shenyang China Recruiting
The Fourth Hospital of Hebei Medical University Shijiangzhuang China Recruiting
Shanxi provincial cancer hospital Taiyuan China Recruiting
Tianjin Medical Universuty Cancer Institute & Hospital Tianjin China Recruiting
Hubei Cancer Hospital Wuhan China Recruiting
The First affiliated hospital of Xi'An Jiao Tong Ubiversity Xi'an China Recruiting
Xuzhou Central Hospital Xuzhou China Recruiting
General Hospital of Ningxia Medical University Yinchuan China Recruiting
The First Affiliated Hospital of Zhenghzou University Zhengzhou China Recruiting

More Antengene Biologics Limited trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05718895 on ClinicalTrials.gov ↗ ← All trials in China