Last updated: April 28, 2024
Sponsor: Antengene Therapeutics Limited
Overall Status: Active - Recruiting
Phase
1
Condition
Neoplasms
Treatment
Pembrolizumab
ATG-037
Keytruda(Pembrolizumab, MK-3475)
Clinical Study ID
NCT05205109
ATG-037-001
KEYNOTE-E73
3475-E73
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 that has relapsed from orrefractory to standard therapies.
- There is at least one measurable lesion according to Response Evaluation Criteria inSolid Tumors (RECIST) version 1.1.
- Estimated life expectancy of a minimum of 12 weeks.
- Subjects with acquired immune checkpoint inhibitors resistance (objective response orSD>6 months).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
- Females should be using adequate contraceptive measures until 180 days after the endof treatment, should not be breastfeeding.
- Male subjects should be willing to use barrier contraception, ie condoms, for theduration of the study and 180 days after the final dose of study treatment.
- Subjects should have adequate organ function.
Exclusion
Exclusion Criteria:
- Primary central nervous system disease, central nervous system metastatic disease,leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.
- Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.
- Patients considered to have rapidly progressive disease (from the starting of priorline therapy to disease progression lasting no more than 90 days).
- 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 product orsystemic anticancer treatment has not been cleared from the body.
- Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with alimited field of radiation for palliation within 14 days of the first dose of studytreatment. Subject must have recovered from all radiation related toxicity, notrequiring corticosteroids.
- Prior major surgery (excluding placement of vascular access) within 28 days of thefirst dose of study treatment or minor surgical procedures ≤7 days.
- Except for alopecia, platinum-induced peripheral neurotoxicity (≤Grade 2). Anyunresolved toxicities from prior therapy greater than Common Terminology Criteria forAdverse Events (CTCAE 5.0) Grade 1 at the time of ICF signature.
- Subjects receiving unstable or increasing doses of corticosteroids.
- As judged by the investigator, any evidence of severe or uncontrolled systemicdiseases, including uncontrolled hypertension defined as a blood pressure (BP) ≥160/100 mmHg despite medical therapy, unstable or uncompensated respiratory and renaldisease, active bleeding diseases, allogeneic stem cell transplantation, or any solidorgan transplant, etc.
Study Design
Total Participants: 98
Treatment Group(s): 4
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
June 07, 2022
Estimated Completion Date:
February 28, 2028
Study Description
Connect with a study center
Calvary Mater Newcastle
Sydney, New South Wales 2298
AustraliaActive - Recruiting
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaActive - Recruiting
Southern Oncology Clinical Research Unit
Bedford Park, South Australia 5042
AustraliaActive - Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria 3199
AustraliaActive - Recruiting
One Clinical Research Pty Ltd
Mount Pleasant, Western Australia WA6153
AustraliaActive - Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing 400000
ChinaActive - Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
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