Clinical trial NCT05718895: A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors
Official title: An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced/Metastatic Solid Tumors
Lead sponsor: Antengene Corporation
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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

Brief 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.

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.

Primary outcomes:
measure: DLT
timeFrame: Up to 21 Days
measure: MTD
timeFrame: Up to 21 Days
measure: RP2D
timeFrame: Up to 21 Days
Secondary outcomes:
measure: PFS
timeFrame: 12 months after the last subject enrolled
measure: ORR
timeFrame: 12 months after the last subject enrolled
measure: DOR
timeFrame: 12 months after the last subject enrolled
Other outcomes:
measure: OS
timeFrame: 12 months after the last subject enrolled
Locations:
city: Adelaide
country: Australia
facility: Cancer Research SA Pty Ltd
city: Malvern
country: Australia
facility: Cabrini Health Limited
city: South Brisbane
country: Australia
facility: Integrated Clinical Oncology Network Pty Ltd (Icon)
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Jinan
country: China
facility: Jinan Central Hospital
city: Lanzhou
country: China
facility: Gansu provincial cancer hospital [recruiting]
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Tongren Hospital Shanghai
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
city: Shijiangzhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi provincial cancer hospital
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an
country: China
facility: The First affiliated hospital of Xi'An Jiao Tong Ubiversity
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
Study officials:
References: