Phase
Condition
Neoplasms
Treatment
ATG-022
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated, written informed consent prior to any study-specificprocedures, sampling, and analyses.
Aged at least 18 years as of the date of consent.
Histological or cytological confirmation of a solid tumor, and have progresseddespite standard therapy(ies), or are intolerant to standard therapy(ies), or notapplicable for standard therapy(ies).
Dose Escalation Phase: all solid tumors.
Dose Expansion Phase: Claudin 18.2 positive solid tumors.
Subjects should be willing to receive a biopsy at screening, if no former availabletumor tissue samples within 36 months prior to participating in the study areprovided.
At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Estimated life expectancy of a minimum of 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .
Females should be using adequate contraceptive measures until 180 days after the endof treatment, should not be breastfeeding, and must have a negative pregnancy testprior to the start of dosing if of child-bearing potential or must have evidence ofnonchild-bearing potential by fulfilling one of the following criteria at screening
Male subjects should be willing to use effective contraception, ie condoms, for theduration of the study and 180 days after the final dose of study treatment.
Exclusion
Exclusion Criteria:
Primary central nervous system disease or central nervous system metastatic disease.
Prior exposure to a Claudin 18.2 targeting agent.
Prior therapy with any chemotherapy, immunotherapy, anticancer agents, orinvestigational products from a previous clinical study within 28 days of the firstdose of study treatment or within a period during which the investigational productor systemic anticancer treatment has not been cleared from the body (eg, a period of 5 'half-lives'.
Prior vaccination within 28 days of the first dose of study therapy.
Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cellinfusion < 6 months prior to the first dose of study treatment.
Active infection including hepatitis B, and/or hepatitis C.
Known history of human immunodeficiency virus (HIV) infection.
Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICFsignature, with the exception of alopecia.
Pregnant or nursing females.
History of hypersensitivity or history of allergic reactions attributed to drugswith a similar chemical or biologic structure or class to ATG-022.
Other primary malignancies developed within 5 years prior to the first dose of thestudy drug, except locally curable malignancies after radical treatment .
In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocolcompliance or may be unsuitable for participation in the study.
Study Design
Study Description
Connect with a study center
Cancer Research SA Pty Ltd
Adelaide,
AustraliaCompleted
Cabrini Health Limited
Malvern,
AustraliaActive - Recruiting
Integrated Clinical Oncology Network Pty Ltd (Icon)
South Brisbane,
AustraliaActive - Recruiting
West China Hospital, Sichuan University
Chengdu,
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou,
ChinaActive - Recruiting
Jinan Central Hospital
Jinan,
ChinaActive - Recruiting
Gansu provincial cancer hospital [recruiting]
Lanzhou,
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University
Qingdao,
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center
Shanghai,
ChinaActive - Recruiting
Tongren Hospital Shanghai
Shanghai,
ChinaActive - Recruiting
Liaoning Cancer Hospital
Shenyang,
ChinaActive - Recruiting
The Fourth Hospital of Hebei Medical University
Shijiangzhuang,
ChinaActive - Recruiting
Shanxi provincial cancer hospital
Taiyuan,
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan,
ChinaActive - Recruiting
The First affiliated hospital of Xi'An Jiao Tong Ubiversity
Xi'an,
ChinaActive - Recruiting
Xuzhou Central Hospital
Xuzhou,
ChinaActive - Recruiting
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