ALKOVE-1

• Research type

  Research Study

• Full title

  A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

• IRAS ID

  1005437

• Contact name

  Virginia Vetter

• Contact email

  vvetter@nuvalent.com

• Sponsor organisation

  Nuvalent, Inc.

• Eudract number

  2022-000122-21

• Clinicaltrials.gov Identifier

  NCT05384626

• Research summary

  This is a first-in-human, Phase 1/2, multicentre, open-label, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the Recommended Phase 2 dose (RP2D) and, if applicable, the Maximum Tolerated Dose (MTD), and evaluate the antitumor activity in patients with advanced ALK-positive Non-small cell lung cancer (NSCLC) and other advanced ALK-positive solid tumours. The study will be conducted in 2 phases.
  Approximately 12 sites for Phase 1 and approximately 60 sites globally for Phase 2 are planned for this study.
  Approximately 20 patients are anticipated to be included in the study from 2 participating trial sites in the United Kingdom, with Dr Anna Minchom serving as the National Coordinating Investigator.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  22/LO/0843

• Date of REC Opinion

  19 Jan 2023

• REC opinion

  Further Information Favourable Opinion