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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: 04 Dec 2025

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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

  • 17 Nov 2025 According to a Nuvalent media release, Additionally, company plans to present detailed study results at a future medical meeting.
  • 17 Nov 2025 According to a Nuvalent media release, The company plans to discuss the topline pivotal data for TKI pre-treated ALK-positive NSCLC with the U.S. Food and Drug Administration (FDA) at a pre-New Drug Application (NDA) meeting.
  • 17 Nov 2025 Topline results presented in the Nuvalent Media Release.

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