Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eucure (Beijing) Biopharma Co., Ltd

Criteria

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 (β -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.