OncoMatch/Clinical Trials/NCT05384626
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Is NCT05384626 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies Neladalkib (NVL-655) for locally advanced solid tumor.
Treatment: Neladalkib (NVL-655) — Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: ALK activating mutation
Required: ALK rearrangement
Demographics
Prior therapy
Cannot have received: ongoing anticancer therapy
Ongoing or anticancer therapy
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Irvine Medical Center · Orange, California
- University of California, Davis Comprehensive Cancer Center · Sacramento, California
- Stanford Cancer Institute · Stanford, California
- University of Colorado Cancer Center · Aurora, Colorado
- Georgetown University Medical Center · Washington D.C., District of Columbia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05384626 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ongoing anticancer therapy disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK activating mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK rearrangement is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify