Trial Title:
A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors
NCT ID:
NCT05718895
Condition:
Advanced/Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg
Q3W with 1 subject
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ATG-022
Description:
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.
Arm group label:
ATG-022
Summary:
This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with
Advanced/metastatic Solid Tumors
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Research SA Pty Ltd
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kelly Kelly Mead
Email:
kmead@cancerresearchsa.com.au
Investigator:
Last name:
SARWAN BISHNOI, Doctorate
Email:
Principal Investigator
Facility:
Name:
Cabrini Health Limited
Address:
City:
Malvern
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Deb Macdonald
Email:
researchgovernance@cabrini.com.au
Investigator:
Last name:
SHEHARA MENDIS, MD
Email:
Principal Investigator
Facility:
Name:
Integrated Clinical Oncology Network Pty Ltd (Icon)
Address:
City:
South Brisbane
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Senior Operations Manager
Email:
CFRemittances@Icon.team
Investigator:
Last name:
Jermaine COWARD
Email:
Principal Investigator
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zheng, MD
Email:
18980601950@163.com
Investigator:
Last name:
Li Zheng, MD
Email:
Principal Investigator
Investigator:
Last name:
Dan Cao, MD
Email:
Principal Investigator
Facility:
Name:
Gansu provincial cancer hospital [recruiting]
Address:
City:
Lanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuhua Liu, MD
Email:
tianlujyx@163.com
Investigator:
Last name:
Yuhua Liu, MD
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jing Lv, MD
Email:
qdfy82912773@126.com
Investigator:
Last name:
Jing Lv, MD
Email:
Principal Investigator
Facility:
Name:
Tongren Hospital Shanghai
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianjun Zhang, MD
Email:
robustzhang168@aliyun.com
Investigator:
Last name:
Jianjun Zhang, MD
Email:
Principal Investigator
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingdong Zhang, MD
Email:
jdzhang@cancerhosp-ln-cmu.com
Investigator:
Last name:
Jingdong Zhang, MD
Email:
Principal Investigator
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiangzhuang
Country:
China
Status:
Recruiting
Contact:
Last name:
Qun Zhao, MD
Email:
zhaoqun516@126.com
Investigator:
Last name:
Qun Zhao, MD
Email:
Principal Investigator
Facility:
Name:
Shanxi provincial cancer hospital
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinfeng Ma, MD
Email:
mjinfeng99@163.com
Investigator:
Last name:
Jinfeng Ma, MD
Email:
Principal Investigator
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinjun Liang, MD
Email:
459992533@qq.com
Investigator:
Last name:
Xinjun Liang, MD
Email:
Principal Investigator
Start date:
March 27, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Antengene Biologics Limited
Agency class:
Industry
Source:
Antengene Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05718895
