Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

NCT05384626 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Neladalkib (NVL-655)

Study Locations (20)

California

  • University of California Irvine Medical Center — Orange
  • University of California, Davis Comprehensive Cancer Center — Sacramento
  • Stanford Cancer Institute — Stanford

Massachusetts

  • Massachusetts General Hospital — Boston
  • Dana Farber Cancer Institute — Boston

New York

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York
  • Memorial Sloan Kettering Cancer Center — New York

Colorado

  • University of Colorado Cancer Center — Aurora

District of Columbia

  • Georgetown University Medical Center — Washington D.C.

Florida

  • University of Miami; Sylvester Cancer Center — Miami

Georgia

  • Winship Cancer Institute, Emory University — Atlanta

Illinois

  • University of Chicago Medical Center — Chicago

Trial Details

FieldValue
Enrollment Target 840 participants
Start Date 2022-06-09
Est. Completion 2028-01
Phase Phase 1

Sponsor

Nuvalent

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05384626

The ClinicalTrials.gov registry entry for NCT05384626 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 840 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nuvalent, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which Neladalkib (NVL-655) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05384626 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05384626 about?

NCT05384626 is a clinical study titled "A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)". 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 evalu...

What is the current status of trial NCT05384626?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 840 participants. The study started on 2022-06-09. Estimated completion is 2028-01.

What conditions does trial NCT05384626 study?

This clinical trial studies the following conditions: Metastatic Solid Tumor, Locally Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05384626?

The interventions under investigation include: Neladalkib (NVL-655) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05384626?

This trial is sponsored by Nuvalent, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05384626 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial