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RecruitingLast updated: 14 May 2024

This study is assessing how safe and effective a new targeted therapy (called ABBV-453) is in people with relapsed or refractory multiple myelomaFirst-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma

Clinical summary

Summary

Eligible participants will receive escalating doses of ABBV-453 (a BCL2 inhibitor) which will be administered via oral tablet once daily.

Conditions

This trial is treating patients with relapsed or refractory multiple myeloma

Cancer

Blood Cancers Haematological

Age

People19+

Phase

I

More information

Trial Identifiers

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

Trial sponsor

AbbVie

Scientific Title

First-in-Human Study of the BCL-2 Inhibitor ABBV-453 in Biomarker-Selected Subjects With Relapsed or Refractory Multiple Myeloma

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status <= 1.
  • Laboratory values meeting the criteria outlined in the protocol.
  • Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
  • Has measurable disease at screening as defined in the protocol.
  • Locally documented or centrally determined t(11;14) positive status and/or centrally determined BCL2high status. Note: If local testing for t(11;14) is discordant with central testing for t(11;14) status, a detailed review of central and local results for t(11;14) status is required to ensure the participants' safety.
  • Part 1 and Part 2, Arm 1 Only: Refractory to or intolerant of all established MM therapies that are known to provide clinical benefit and are triple class exposed to a proteasome inhibitors (PI), an Immunomodulatory drugs (IMID), and an anti-CD38 monoclonal antibody in previous line(s) of therapy.
  • Part 2, Arms 2 and 3 Only: Received 1 to 3 prior lines of therapy, including a PI or an IMiD.
  • Part 1 only: Permitted to be venetoclax or BCL-2 inhibitor exposed in previous lines of therapy.
  • Life expectancy >= 12 weeks.

Exclusion

  • Clinically relevant or significant Electrocardiogram (ECG) abnormalities as outlined in the protocol.
  • Part 2 only: Previous treatment with venetoclax or BCL-2 inhibitor.
  • Part 2, Arms 2 and 3 only: Prior daratumumab or other anti-CD38 therapy exposure that meets any of the criteria outlined in the protocol.

Inclusion

  • You have had treatment, but your cancer has come back.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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

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