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Closed (no longer recruiting)Last updated: 28 November 2023

This phase I trial is evaluating a new targeted therapy in patients with advanced cancers and cancers that have spread to other parts of the bodyFirst-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Clinical summary

Summary

Eligible patients will receive intravenous ADG116 on Day 1 of each treatment cycle.

Conditions

This trial is treating patients with advanced solid cancer (excluding some types of blood cancer).

Cancer

Multi-Cancer Multi-Cancer

Age

People18 - 75

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Adagene Inc

Scientific Title

First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Eligibility

Inclusion

  • Male or female, 18-75 years of age at the time of consent.
  • Provide written informed consent.
  • Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
  • Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will also be recruited if they meet all eligibility criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2.
  • Adequate organ and bone marrow function
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study

Exclusion

  • Pregnant or nursing females.
  • Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
  • Grade ≥ 3 immune-related adverse events (irAE) or irAE that lead to discontinuation of prior immunotherapy. Untreated or uncontrolled central nervous system (CNS) tumors or metastases
  • Any active autoimmune disease or documented history of autoimmune disease.
  • Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • Subjects requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
  • Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis. Peripheral neuropathy ≥ Grade 2.
  • History of clinically significant cardiac disease.
  • Uncontrolled current illness.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.