Clinical Trial 22199-A

• Overview

  Study Title:

  TACTIVE-U: An Interventional Safety and Efficacy Phase 1b/2, Open-Label Umbrella Study To Investigate Tolerability, PK, and Antitumor Activity of Vepdegestrant (ARV-471/PF-07850327), An Oral Proteolysis Targeting Chimera, In Combination With Other Anticancer Treatments in Participants Aged 18 Years and Over With ER+ Advanced or Metastatic Breast Cancer, Sub-Study A (ARV-471 In Combination With Abemaciclib)

  Summary:

  The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer.

  Objective:

  Objectives: To assess safety and tolerability of ARV-471 in combination with abemaciclib in participants with ER+/HER2- A/MBC to select a RP2D. To evaluate the overall safety profile. To evaluate antitumor activity of ARV-471 in combination with abemaciclib. To evaluate the plasma exposure of ARV-471, ARV-473, and abemaciclib when ARV-471 and abemaciclib are given in combination.

• Treatments

  Therapies:

  Chemotherapy (NOS)

  Medications:

  ARV-471 (); Abemaciclib (); LY2835219 (Abemaciclib)

• Inclusion Criteria

  • Histological or cytological diagnosis of ER+ and HER2- advanced/metastatic breast cancer that is not amendable to surgical resection with curative intent (>1% ER+ stained cells on the most recent tumor biopsy)
  • Prior anticancer therapies: up to 2 lines of prior therapies for advanced/metastatic disease; 1 line of any CDK4/6 inhibitor-based regimen is required (independent of the setting eg, adjuvant or advanced/metastatic)
  • At least 1 measurable lesion as defined by RECIST v1.1
  • ECOG PS <1>

• Exclusion Criteria

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  • Visceral crisis at risk of life-threatening complications in the short term
  • Known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions.
  • Newly diagnosed brain metastases, or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 14 days prior to enrollment in the study.
  • History of any other tumor malignancies within the past 3 years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix.
  • Inflammatory breast cancer
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • Concurrent administration of medications, food, or herb supplements that are strong inhibitors and strong/moderate inducers of CYP3A and drugs known to predispose to Torsade de Pointes or QT interval prolongation.
  • Renal impairment, not adequate liver function and/or bone marrow function
  • Known active infection

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