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A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 and ABBV-368 With and Without ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

Conditions

Lung | Breast

Phase I

What is the purpose of this trial?

A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 + ABBV-368 with and without ABBV-181 in participants with selected solid tumors. This study consists of 2 main parts, dose-escalation and dose-expansion phases.

The trial will begin with dose escalation in Arm A (ABBV-927 + ABBV-368) which determines the recommended Phase 2 dose (RP2D)/maximum-tolerated dose (MTD) of ABBV-927 when administered with ABBV-368. Once the RP2D/MTD is defined in Arm A, enrollment will begin in the following arms: Arm 1 (ABBV-927 + ABBV-368) at the RP2D/MTD established in Arm A; Arm 2 (ABBV-927 + ABBV-368) at the RP2D/MTD established in Arm A; Arm B (ABBV-927 + ABBV-368 + ABBV-181) dose escalation. Once the RP2D/MTD is defined in Arm B, enrollment will begin in the following arms: Arm 3 (ABBV-927 + ABBV-368); Arm 4 (ABBV-927 + ABBV-368 + ABBV-181); Arm 5 (docetaxel).

  • Trial with
    AbbVie Inc.
  • Start Date
    01/12/2020
  • End Date
    05/10/2023
Trial Image

For more information about this study, contact:

Ingrid Palma

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343

  • Last Updated
    05/29/2020
  • Study HIC
    #2000025780