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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05040932
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Eucure (Beijing) Biopharma Co., Ltd

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cancer Drug: YH004 Phase 1

Detailed Description:
This is an open-label, non-randomized, two-stage, FIH Phase 1 study, utilizing an accelerated dose escalation followed by a traditional 3 + 3 dose escalation algorithm to identify the MTD and/or RP2D of YH004 as a single agent (monotherapy) and in combination with Toripalimab. The first stage of the study is the dose escalation phase (i.e., Phase 1a). The second stage of the study is the dose expansion phase (i.e., Phase 1b). During the study, dose interruption(s) and/or delay(s) may be implemented based on toxicity. Dose modifications are permitted following protocol guidelines. Intra-patient dose escalations will be allowed for the early dose cohorts (single-patient dose groups) in Phase 1a. Patients will be considered evaluable for safety and tolerability if they receive at least one dose of YH004 or Toripalimab at the specified cohort dose. Patients in all parts of the trial will remain on therapy until confirmed disease progression or for 1 year, whichever occurs first. However, patients who are clinically unstable will discontinue following the initial assessment of disease progression.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: YH004
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
IV infusion once every 3 weeks (Q3W).


Outcome Measures
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Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs) [ Time Frame: up to 24 months ]
    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

  2. Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) [ Time Frame: up to 24 months ]
    The MTD and/or RP2D will be determined based on TEAEs


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05040932


Contacts
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Contact: Fangxia Pan +86 010 85950770 ext 8006 fangxia.pan@eucure.com

Locations
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Australia
Cabrini Health Limited Recruiting
Malvern East, Australia, 3144
Contact: Anis Hamid    (03)95083434    research@cabrini.com.au   
Westmead Hospital Not yet recruiting
Sydney, Australia, 2145
Contact: Mark Wong    02 8890 5555      
Southside Cancer Care Centre, School of Medicine, University of Wollongong Not yet recruiting
Wollongong, Australia, 2217
Contact: Paul de Desouza, PhD    +61 (0)2 4221 5905 9744    paulds@uow.edu.au   
Sponsors and Collaborators
Eucure (Beijing) Biopharma Co., Ltd
Investigators
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Study Chair: Rong Chen, Ph.D Eucure (Beijing) Biopharma Co., Ltd
More Information
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Responsible Party: Eucure (Beijing) Biopharma Co., Ltd
ClinicalTrials.gov Identifier: NCT05040932    
Other Study ID Numbers: YH004002
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eucure (Beijing) Biopharma Co., Ltd:
Eucure
YH004
anti-4-1BB
Toripalimab
anti-PD-1