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No longer recruiting (closed or complete)Last updated: 2 February 2024

YH004002: This phase I study is seeking to determine the best dose level and effectiveness of a new targeted therapy (YH004) alone, and in combination with immunotherapy (toripalimab) in people with advanced solid cancers and relapsed or refractory non-Hodgkin lymphomaA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18 - 80

Trial acronym

YH004002

Clinical summary

Summary

This study has two stages: dose escalation (phase 1a) and dose expansion (phase 1b). Phase 1a includes 7 dose levels of YH004, and the highest dose is up to 10mg/kg. YH004 will be given via intravenous infusion once every 3 weeks.

Conditions

This trial is treating people with advanced solid cancer and relapsed or refractor non-Hodgkin lymphoma

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has not spread to other parts of the body (localised).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Eucure (Beijing) Biopharma Co., Ltd

Scientific 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

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