Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy
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|ClinicalTrials.gov Identifier: NCT05040932|
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : October 3, 2022
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
IV infusion once every 3 weeks (Q3W).
- 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
- 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
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
|Contact: Fangxia Pan||+86 010 85950770 ext firstname.lastname@example.org|
|Cabrini Health Limited||Recruiting|
|Malvern East, Australia, 3144|
|Contact: Anis Hamid (03)95083434 email@example.com|
|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 firstname.lastname@example.org|
|Study Chair:||Rong Chen, Ph.D||Eucure (Beijing) Biopharma Co., Ltd|