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Study of Neladalkib (NVL-655) for ALK-Positive Cancers

This study is testing a new oral tablet called Neladalkib (NVL-655) for people with advanced solid tumors, including non-small cell lung cancer (NSCLC), that have an ALK rearrangement or mutation. ALK is a specific change in cancer cells that can be targeted by certain medicines. The study aims to find a safe and effective dose of Neladalkib (NVL-655) and see how well it shrinks tumors. You might be eligible if you have an ALK-positive cancer and are at least 12 years old, depending on the specific part of the study. The study also includes other medications like Midazolam, Repaglinide, and Itraconazole to understand how Neladalkib (NVL-655) interacts with other drugs. The study is currently unclear on its recruitment status and plans to enroll 840 participants.

Study design
This is a Phase 1/2 study that will first find a safe dose of Neladalkib (NVL-655) and then test how well it works. It is designed to enroll 840 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works for 2-3 years after the first patient receives the drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Recruiting
PHASE1Ages 12+InterventionalTreatment
Nuvalent Inc.
~840 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Neladalkib (NVL-655)MidazolamRepaglinideItraconazole

At a glance

Recruiting sites
73 of 74 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities (DLTs) (Phase 1)
Measured over Within the first 21 days of the first neladalkib (NVL-655) dose
+6 more outcomes measured

Conditions

Locally Advanced Solid Tumor
Metastatic Solid Tumor

Explore related trials

Lung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

74 sites across 37 states
Italy7
Japan7
Spain5
France4
Germany4
California3
South Korea3
Taiwan3

Study leadership

  • Viola Zhu, MD, PHD · STUDY_DIRECTOR · Nuvalent Inc.

Who to contact

Nuvalent Clinical Trial
[email protected]
857-357-7000
Email the study team

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What this trial measures

  • Dose limiting toxicities (DLTs) (Phase 1)Within the first 21 days of the first neladalkib (NVL-655) dose

    Define the dose limiting toxicities (DLTs)

  • Recommended Phase 2 Dose (RP2D) (Phase 1)Within 21 days of last patient dosed during escalation

    To determine the RP2D

  • Objective Response Rate (ORR) (Phase 2)2-3 years after first patient dosed.

    To determine ORR as assessed by BICR

  • Number of participants with treatment-emergent adverse events, as assessed by CTCAE, V5.0 (Phase 1)Approximately 3 years

    Incidence and severity of treatment-emergent adverse events (TEAEs)

  • Area under the curve of repaglinide (Phase 2 DDI sub-study)Pre-dose and up to 24 hours post-dose

    To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of repaglinide

  • Area under the curve of midazolam (Phase 2 DDI sub-study)Pre-dose and up to 24 hours post-dose

    To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of midazolam

  • Area under the curve of neladalkib (NVL-655) (Phase 2 DDI sub-study)Pre-dose and up to 24 hours post-dose

    To determine the effect of itraconazole on the single oral dose PK of neladalkib (NVL-655)