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

NCT05718895 | Recruiting Phase 1

• 1 other identifier: ATG-022-ST-001
• Study Type: interventional
• Target: 156
• Locations: 2 countries
• Sites: 22

Brief Summary

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

Conditions

Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (3)

• DLT

  Number of Participants with Dose Limiting Toxicity

  Up to 21 Days

• MTD

  Maximum Tolerated Dose

  Up to 21 Days

• RP2D

  RP2D= Recommended Phase 2 Dose

  Up to 21 Days

Secondary Outcomes (3)

• PFS

  12 months after the last subject enrolled

• ORR

  12 months after the last subject enrolled

• DOR

  12 months after the last subject enrolled

Other Outcomes (1)

• OS

  12 months after the last subject enrolled

Study Arms (1)

ATG-022

EXPERIMENTAL

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

Interventions

ATG-022 DRUG

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.

ATG-022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
• Aged at least 18 years as of the date of consent.
• 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).
• Dose Escalation Phase: all solid tumors.
• Dose Expansion Phase: Claudin 18.2 positive solid tumors.
• 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.
• At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
• Estimated life expectancy of a minimum of 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .
• 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
• 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.

You may not qualify if:

• Primary central nervous system disease or central nervous system metastatic disease.
• Prior exposure to a Claudin 18.2 targeting agent.
• 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'.
• Prior vaccination within 28 days of the first dose of study therapy.
• Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion \< 6 months prior to the first dose of study treatment.
• Active infection including hepatitis B, and/or hepatitis C.
• Known history of human immunodeficiency virus (HIV) infection.
• Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.
• Pregnant or nursing females.
• History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022.
• Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .
• 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.

Sponsors & Collaborators

• Antengene Biologics Limited: lead

Study Sites (22)

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

Central Study Contacts

Felix Li

CONTACT

021-32501095; felix.li@antengene.com

Sunny He

CONTACT

sunny.he@antengene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg Q3W with 1 subject

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 8, 2023
• Study Start: March 27, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (19); AU (3)