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

NCT05040932 | Completed Phase 1 DMC

• 1 other identifier: YH004002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer

Keywords

Eucure; YH004; anti-4-1BB; Toripalimab; anti-PD-1

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

YH004

EXPERIMENTAL

The dose escalation phase includes 7 dose levels of YH004, and the highest dose is up to 10mg/kg. Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 16 cycles if patients receive benefits.

Drug: YH004

Interventions

YH004 DRUG

IV infusion once every 3 weeks (Q3W).

YH004

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eucure (Beijing) Biopharma Co., Ltd: lead

Study Sites (3)

Cabrini Health Limited

Malvern East, 3144, Australia

Location

Westmead Hospital

Sydney, 2145, Australia

Location

Southside Cancer Care Centre, School of Medicine, University of Wollongong

Wollongong, 2217, Australia

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rong Chen, Ph.D

  Eucure (Beijing) Biopharma Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 10, 2021
• Study Start: December 7, 2021
• Primary Completion: July 16, 2023
• Study Completion: July 16, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

AU (3)