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: 05 Jun 2026
Price :
$35
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At a glance
- Drugs Neladalkib (Primary) ; Itraconazole; Midazolam; Repaglinide
- 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
- 02 Jun 2026 Results presented at the 62nd Annual Meeting of the American Society of Clinical Oncology
- 27 May 2026 According to a Nuvalent media release, Phase 1 portion enrolled previously treated ALK-positive NSCLC and other ALK-positive solid tumor patients to assess the safety, tolerability, pharmacokinetics, preliminary efficacy, and RP2D of neladalkib. The ongoing global Phase 2 trial is evaluating neladalkib in TKI-pretreated advanced ALK-positive NSCLC patients with registrational intent, while enrollment continues for patients with other ALK-positive solid tumors and adolescent NSCLC patients.
- 27 May 2026 According to a Nuvalent media release, the company announced the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. The submission is based on data of this global, registration-directed ALKOVE-1 Phase trial.