Study on 23ME-01473 for Patients with Advanced Solid Cancers

Sponsor: 23andMe, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06290388

Provider View

This clinical trial is testing a new drug, 23ME-01473, to see if it is safe and effective for people with advanced solid cancers that have not responded to standard treatments. The drug is given through an IV infusion.

Patient Parameters

Program Overview

This study is the first time 23ME-01473 is being tested in humans. It aims to find out if the drug is safe and how it behaves in the body. Participants are adults with advanced solid cancers that have either worsened despite standard treatments or cannot tolerate them. The study will also explore the drug's potential to help treat these cancers.

Description

The trial includes a phase where different doses of 23ME-01473 are tested to find the highest dose that can be given safely. This phase will help determine the best dose to use in future studies. Researchers will closely monitor participants to see how their bodies process the drug and how it affects their cancer. The study is open to adults with various types of advanced solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Have a confirmed diagnosis of advanced or metastatic cancer that has not responded to standard treatments.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Have cancer that can be evaluated for progression, regardless of the type.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have an active autoimmune disease requiring treatment in the last 2 years.
  • Have used systemic immunosuppressive therapy, like steroids, within 4 weeks before starting the study.
  • Have a history of serious lung conditions or immune-related side effects.
  • Have had a bone marrow or organ transplant.
  • Have active hepatitis C or B, unless treated and under control.
  • Have HIV, unless well-controlled with a stable treatment regimen.
  • Have received cancer treatments like chemotherapy or immunotherapy recently.
  • Have had another cancer in the last 2 years, unless treated and disease-free.
  • Have uncontrolled cancer spread to the brain or spinal cord.
  • Have had serious heart problems in the last 6 months.

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