Study on ABL103 and Pembrolizumab, With or Without Taxane, for Advanced or Metastatic Solid Tumors

Sponsor: ABL Bio, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07158918

This clinical trial is testing the safety and effectiveness of a new treatment combining ABL103 and pembrolizumab, with or without an additional drug called taxane, in adults with advanced or metastatic solid tumors.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective a new treatment is for people with advanced or metastatic solid tumors. The treatment involves using a combination of ABL103 and pembrolizumab, with or without taxane. Researchers want to see if this combination can help control the cancer and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic solid tumor that cannot be surgically removed.
  • Cancer must have returned after treatment or not responded to standard treatments, or the patient cannot tolerate 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.
  • Must have recovered from side effects of previous treatments to a mild level or baseline, except for hair loss or stable, irreversible side effects.
  • Must have adequate blood, kidney, liver, and thyroid function based on tests.
  • Women who can become pregnant must use effective birth control during the study and for six months after the last dose.
  • Women must have a negative pregnancy test before starting the study.
  • Men with partners who can become pregnant must use contraception and not donate sperm during treatment and for six months after the last dose.
  • Men with pregnant or breastfeeding partners must use a condom or remain abstinent during the study and for six months after the last dose.

Exclusion Criteria

  • Have received previous cancer treatments that have not resolved their effects before starting the study.
  • Have had radiation therapy within two weeks before starting the study or have radiation-related side effects needing steroids.
  • Have had previous immunotherapy stopped due to severe side effects, except for treatable hormone-related issues.
  • Have had radiation to the lungs over a certain dose within six months before starting the study.
  • Have risk factors for bowel problems, such as a history of certain abdominal conditions. Patients with ovarian cancer and a history of abdominal issues may still be eligible.

Locations

FACILITYZIPCITYSTATE
UH Cleveland Medical Center44106ClevelandOhio

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