Clinical trial · Interventional
Study of YH004 (4-1BB Agonist Antibody) in Advanced or Metastatic Malignancy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| YH004 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- YH004
- description
- 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.
- interventionNames
- Drug: YH004
Primary outcomes (2)
- measure
- Treatment-emergent adverse events (TEAEs) including determination of DLTs and serious AEs (SAEs)
- timeFrame
- up to 24 months
- description
- 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
- measure
- Maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available