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: 07 Aug 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

24 Jul 2025 Planned number of patients changed from 470 to 840.
24 Jul 2025 Planned End Date changed from 1 Mar 2026 to 1 Jan 2028.
24 Jul 2025 Planned primary completion date changed from 1 Feb 2026 to 1 Dec 2027.

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