Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-30 @ 3:05 PM
Study NCT ID:
NCT05040932
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy
Sponsor:
Eucure (Beijing) Biopharma Co., Ltd
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: