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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Apr 2026

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At a glance

  • Drugs Neladalkib (Primary)
  • Indications Advanced breast cancer; Anaplastic large cell lymphoma; Brain metastases; Carcinoma; Cholangiocarcinoma; Colorectal cancer; Diffuse large B cell lymphoma; Male breast cancer; Neuroblastoma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Thyroid cancer
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics; Proof of concept; Registrational; Therapeutic Use
  • Acronyms ALKOVE-1
  • Sponsors Nuvalent

Most Recent Events

  • 21 Apr 2026 According to a Nuvalent media release, data from the trial will be presented will be presented during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 - June 2, 2026, in Chicago.
  • 07 Apr 2026 According to a Nuvalent media release, the company plans to share detailed results at a future medical meeting.
  • 07 Apr 2026 According to a Nuvalent media release, the company has submitted New Drug Application (NDA) based on data of this this trial to the U.S. Food and Drug Administration (FDA).

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