Cancer Clinical Trial
Official title:
A First-In-Human, Multicenter, Open-Label, Phase I Dose Escalation Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of YH004 As A Single Agent And Combination With Toripalimab In Subjects With Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
Verified date | September 2023 |
Source | Eucure (Beijing) Biopharma Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
YH004 is a humanized monoclonal antibody that specifically binds to 4-1BB, and acts as an agonist against 4-1BB. This first in human study of YH004 is designed to establish the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of YH004, both as a single agent (monotherapy) and in combination with a fixed dose of anti-PD-1 antibody (Toripalimab) in the treatment of advanced solid tumors and relapsed or refractory non-Hodgkin Lymphoma.
Status | Completed |
Enrollment | 8 |
Est. completion date | July 16, 2023 |
Est. primary completion date | July 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Males or females aged 18 years to 80 years at the time of screening. - Ability to understand and willingness to sign a written informed consent document. - Subjects must have advanced histologically or cytologically confirmed solid tumor or relapsed or refractory Non-Hodgkin lymphoma. - Adequate bone marrow, liver, and renal functions. - Men and women of childbearing potential must agree to take highly effective contraceptive methods. - Women of reproductive potential must have negative serum beta human chorionic gonadotropin (ß -HCG) pregnancy test within 7 days of the first dose. Exclusion Criteria: - Receipt of systemic anticancer therapy including investigational agents or devices within 5 half-lives of the first dose of study treatment. - Known active CNS metastasis. - Has received a live-virus vaccine within 28 days. - History of clinically significant sensitivity or allergy to monoclonal antibodies and their excipients or known allergies to antibodies produced from Chinese hamster ovary cells. - Abnormality of QT interval or syndrome. - Patients with history of Grade = 3 immune-related AEs (irAEs) or irAE. - Patients who receive concurrent or prior use of an immunosuppressive agent within 4 weeks of the first dose of study drug. - Previous exposure to anti-CD137 (eg, utomilumab, urelumab) antibodies. . - Active or chronic autoimmune disease that has required systemic treatment in the past 3 years or who are receiving systemic therapy for an autoimmune or inflammatory disease. - Has a clinically significant cardiac condition, including unstable angina, acute myocardial infarction within 6 months. - Has an active infection before the first dose of study treatment. - History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease.. - Female patients who are pregnant or breastfeeding. - Any evidence of severe or uncontrolled systemic disease. - Any condition that the investigator or primary physician believes may not be appropriate for participating the study. |
Country | Name | City | State |
---|---|---|---|
Australia | Cabrini Health Limited | Malvern East | |
Australia | Westmead Hospital | Sydney | |
Australia | Southside Cancer Care Centre, School of Medicine, University of Wollongong | Wollongong |
Lead Sponsor | Collaborator |
---|---|
Eucure (Beijing) Biopharma Co., Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs) | Adverse events will be assessed, and severity will be assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | up to 24 months | |
Primary | Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) | The MTD and/or RP2D will be determined based on TEAEs | up to 24 months |
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