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RecruitingLast updated: 2 February 2024

Adagene: This study is assessing how safe and effective different dose levels of targeted therapy are in people with advanced and metastatic solid cancersA First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors

Clinical summary

Summary

This is a dose escalation study that is evaluating how safe, tolerable and effective a new targeted therapy (ADG206) is in people with advanced or metastatic solid cancers. All participants will receive the study drug (ADG206) at one of the designated dose levels. ADG206 will be administered by intravenous infusion (IV) over 60-90 minutes on Day 1 of each treatment cycle.

Conditions

This trial is treating patients with advanced or metastatic solid cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

Adagene

More information

Trial Identifiers

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Trial sponsor

Adagene Inc

Scientific Title

A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.
  • At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
  • Adequate organ function.
  • Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.
  • Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.

Exclusion

  • Subjects within washout period of other anti-tumor therapies. .
  • History of prior malignancy other than the cancer under treatment in the study.
  • Major trauma or major surgery within 4 weeks before the first dose of study drug.
  • Serious nonhealing wound, ulcer, or bone fracture.
  • History of significant immune-mediated AE.
  • Central nervous system (CNS) disease involvement.
  • Any evidence of underlying severe liver dysfunction.
  • Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.
  • Clinically significant cardiac disease with insufficient cardiac function.
  • Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
  • Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
  • Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled) .
  • History or risk of autoimmune disease.
  • Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.
  • Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.
  • Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.
  • Pregnant, lactating, or breastfeeding.

Inclusion

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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • 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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