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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 Mar 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; Therapeutic Use
  • Acronyms ALKOVE-1
  • Sponsors Nuvalent

Most Recent Events

  • 27 Feb 2025 According to a Nuvalent media release, the company expects to submit NDA by mid-year 2025.
  • 13 Jan 2025 According to a Nuvalent media release, as of December 31, 2024, a total of 596 patients enrolled in this trial. The company expects to report pivotal data from this trial in by year end 2025.
  • 14 Sep 2024 According to a Nuvalent media release, the company expects to report pivotal data from this trial in 2025.

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