Actively Recruiting
An Open, Multi-center, Phase I Clinical 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ATG-022 in patients with advanced or metastatic solid tumors in this Phase I, multi-center, open-label clinical trial. The study aims to find the best dose of ATG-022 and to assess its safety and how well it is tolerated. The trial includes patients whose tumors have progressed despite standard treatments or who cannot undergo standard therapies, with a focus on solid tumors and those expressing Claudin 18.2 in the Dose Expansion Phase. The study consists of two main parts: a Dose Escalation Phase and a Dose Expansion Phase. In the Dose Escalation Phase, patients receive ATG-022 in cycles of 21 days, starting with a low dose of 0.3 mg/kg every three weeks, increasing through defined dose levels to find the maximum tolerated dose. The Dose Expansion Phase enrolls up to 120 patients with Claudin 18.2-positive tumors at the recommended dose to further evaluate safety and efficacy. Participants will undergo biopsies if recent tumor samples are unavailable and must have measurable tumors per RECIST v1.1 criteria. Researchers will monitor side effects and dose-limiting toxicities within 21 days and assess progression-free survival, overall response rate, and duration of response up to 12 months after the last patient is enrolled. Women of childbearing potential and men must use contraception during and after the study. The total participation time varies depending on treatment and follow-up schedules.
CONDITIONS
Brief Title
A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Willingness to receive a biopsy at screening if no tumor tissue samples within 36 months are available.
- At least 1 measurable lesion per RECIST v1.1.
- Estimated life expectancy of a minimum of 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Females should use adequate contraception until 180 days after treatment ends, not be breastfeeding, and have a negative pregnancy test if of child-bearing potential.
- Male subjects should use effective contraception during the study and for 180 days after the final dose.
You will not qualify if you...
- Primary central nervous system disease or central nervous system metastatic disease.
- Prior exposure to a Claudin 18.2 targeting agent.
- Prior chemotherapy, immunotherapy, anticancer agents, or investigational products within 28 days before the first study dose or until cleared from the body.
- Prior vaccination within 28 days of the first dose of study therapy.
- Prior solid organ transplant.
- Autologous stem cell transplant or CAR-T cell infusion less than 6 months before the first dose.
- Active infection including hepatitis B or C.
- Known history of HIV infection.
- Unresolved toxicities from prior therapy greater than Grade 1, except alopecia.
- Pregnant or nursing females.
- History of allergic reactions to drugs similar to ATG-022.
- Other primary malignancies within 5 years before first study dose, except locally curable malignancies after radical treatment.
- Conditions or complications 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive ATG-022 treatment in 21-day cycles with dose escalation or expansion depending on their phase in the study.
1 visit every 3 weeks for treatment dosing
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
Research Team
F
Felix Li
S
Sunny He
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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