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Closed (no longer recruiting)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

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 patients with advanced solid cancer and relapsed or refractor non-Hodgkin lymphoma.

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 80

Phase

I

Trial Acronym

YH004002

More information

Trial Identifiers

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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

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.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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.

Ask your doctor if this trial could be right for you.

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