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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05718895




Registration number
NCT05718895
Ethics application status
Date submitted
17/01/2023
Date registered
8/02/2023
Date last updated
10/04/2024

Titles & IDs
Public title
A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors
Scientific title
An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
ATG-022-ST-001
Universal Trial Number (UTN)
Trial acronym
CLINCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced/Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATG-022

Experimental: ATG-022 - 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.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DLT
Timepoint [1] 0 0
Up to 21 Days
Primary outcome [2] 0 0
MTD
Timepoint [2] 0 0
Up to 21 Days
Primary outcome [3] 0 0
RP2D
Timepoint [3] 0 0
Up to 21 Days
Secondary outcome [1] 0 0
PFS
Timepoint [1] 0 0
12 months after the last subject enrolled
Secondary outcome [2] 0 0
ORR
Timepoint [2] 0 0
12 months after the last subject enrolled
Secondary outcome [3] 0 0
DOR
Timepoint [3] 0 0
12 months after the last subject enrolled

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cancer Research SA Pty Ltd - Adelaide
Recruitment hospital [2] 0 0
Cabrini Health Limited - Malvern
Recruitment hospital [3] 0 0
Integrated Clinical Oncology Network Pty Ltd (Icon) - South Brisbane
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Malvern
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Chengdu
Country [2] 0 0
China
State/province [2] 0 0
Lanzhou
Country [3] 0 0
China
State/province [3] 0 0
Qingdao
Country [4] 0 0
China
State/province [4] 0 0
Shanghai
Country [5] 0 0
China
State/province [5] 0 0
Shenyang
Country [6] 0 0
China
State/province [6] 0 0
Shijiangzhuang
Country [7] 0 0
China
State/province [7] 0 0
Taiyuan
Country [8] 0 0
China
State/province [8] 0 0
Wuhan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Antengene Biologics Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors
Trial website
https://clinicaltrials.gov/study/NCT05718895
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Huifen Zheng
Address 0 0
Country 0 0
Phone 0 0
18620667595
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05718895