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

Advanced/Metastatic Solid Tumors Clinical Trial

— CLINCH  

Official title:

An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718895
• Other study ID #: ATG-022-ST-001
• Status: Recruiting
• Phase: Phase 1
• Start date: March 27, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: Antengene Corporation
• Contact: Huifen Zheng
• Phone: 18620667595
• Email: huifen.zheng[@]antengene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced/Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	Cancer Research SA Pty Ltd	Adelaide
Australia	Cabrini Health Limited	Malvern
Australia	Integrated Clinical Oncology Network Pty Ltd (Icon)	South Brisbane
China	West China Hospital, Sichuan University	Chengdu
China	Gansu provincial cancer hospital [recruiting]	Lanzhou
China	The Affiliated Hospital of Qingdao University	Qingdao
China	Tongren Hospital Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang
China	The Fourth Hospital of Hebei Medical University	Shijiangzhuang
China	Shanxi provincial cancer hospital	Taiyuan
China	Hubei Cancer Hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Antengene Biologics Limited

Countries where clinical trial is conducted

Australia,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OS	Overall Survival	12 months after the last subject enrolled
Primary	DLT	Number of Participants with Dose Limiting Toxicity	Up to 21 Days
Primary	MTD	Maximum Tolerated Dose	Up to 21 Days
Primary	RP2D	RP2D= Recommended Phase 2 Dose	Up to 21 Days
Secondary	PFS	Progression Free Survival	12 months after the last subject enrolled
Secondary	ORR	Overall Response Rate	12 months after the last subject enrolled
Secondary	DOR	Duration of Response	12 months after the last subject enrolled