Study of YH004 (4-1BB Agonist Antibody) in Advanced Solid Tumors And Relapsed Or Refractory Non-H… (NCT05564806) | Clinical Trial Compass
UnknownPhase 1
Study of YH004 (4-1BB Agonist Antibody) in Advanced Solid Tumors And Relapsed Or Refractory Non-Hodgkin Lymphoma
China38 participantsStarted 2023-01-31
Plain-language summary
This is an multicenter, open-label, dose-escalation study of the study drug YH004 . The study is designed to determine the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of YH004 in subjects with advanced solid tumors and relapsed or refractory Non-Hodgkin lymphoma.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study procedures.
. Patients with histologically or cytologically confirmed advanced solid tumor or relapsed or refractory Non-Hodgkin Lymphoma (including but not limited to inert and transformed type, patients with inert lymphoma must undergo systematic treatment at the time of screening), which has progressed after treatment with standard therapies or intolerant of standard therapies or have no standard of care.
. Subject must have at least one measurable lesion by RECIST 1.1 or per Cheson criteria (Lugano 2014).
. Subjects must be 18 years to 80 years of age at the time of screening.
. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events (AEs)
Timeframe: up to 1 year after the last dosing
2
Maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D)
. Have life expectancy of at least 12 weeks based on investigator's judgement.
. Sufficient organ and bone marrow functions before screening or administration.
. Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test at the time of screening.
Exclusion criteria
. Previous exposure to an anti-CD137 (e.g., utomilumab, urelumab) antibodies.
. Subjects must not have another active invasive malignancy within 2 years or currently.
. Subjects have received any anticancer therapy or another investigational agent within the longer of 4 weeks or 5 half-lives before the first dose of the study drug.
. Continuance of toxicities due to prior anti-tumor therapy that have not recovered to ≤ Grade 1 per CTCAE 5.0.
. Subjects who have major operations within 4 weeks before the first dose of the study drug, or minor surgery within 2 weeks prior to the first dose.
. Subjects have received any radiotherapy within the longer of 4 weeks before the first dose of the study drug.
. Subjects with primary CNS malignancy or symptomatic CNS metastasis.
. Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy or treatment discontinuation due to previous immunotherapy.