Phase 1/2 Study of ISB 1442 for Treating Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Ichnos Sciences SA

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05427812

Provider View

This clinical trial is testing a new drug, ISB 1442, to see if it is safe and effective for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is the first to test ISB 1442 in humans and is divided into two parts. The first part (Phase 1) will determine the safest dose of the drug for patients with relapsed or refractory multiple myeloma. The second part (Phase 2) will further test the drug at the established dose to see how well it works in treating the disease. Participants will continue receiving ISB 1442 until their disease worsens, they experience unacceptable side effects, or they choose to stop the treatment.

Description

The study is conducted in two phases:

  • Phase 1: This phase involves gradually increasing the dose of ISB 1442 in patients with relapsed or refractory multiple myeloma to find the safest dose.
  • Phase 2: Once the safe dose is determined, this phase will test the effectiveness of ISB 1442 at that dose in a larger group of patients.

Participants will receive the drug until their disease progresses, they experience side effects that cannot be tolerated, or they meet any other criteria for stopping the treatment or withdrawing from the trial.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be willing to provide written consent to participate.
  • For Phase 1: Must have multiple myeloma that has returned or not responded to at least three previous treatments, including specific types of therapies.
  • For Phase 2: Must have multiple myeloma that has returned or not responded to standard treatments.
  • Must weigh at least 40 kg (about 88 pounds).
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Must have a life expectancy of at least 3 months.
  • Must have adequate organ function, including specific liver and kidney function levels.
  • Must have a heart function of at least 45% as measured by specific tests.

Exclusion Criteria

  • Disease relapse characterized only by minimal residual disease.
  • Disease measurable only by plasmacytoma.
  • Recent treatment with certain antibodies or cancer therapies within specified timeframes before starting the study drug.
  • Recent stem cell transplant within 12 weeks before starting the study drug.
  • Participation in another clinical trial within 4 weeks before starting the study drug.
  • Recent radiation therapy within 14 days before starting the study drug.
  • Active cancer involvement in the central nervous system.
  • Known to be unresponsive to blood transfusions.
  • Severe allergic reactions to proteins or ingredients in ISB 1442.
  • Abnormal heart rhythm as indicated by a specific test result.

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