marked.bio

ALK TKI (brain-penetrant, 4th generation) · small molecule

neladalkib

2 active trials, targeting ALK. Not approved for any biomarker on marked.bio yet.

Also known as NVL-655.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
ALK fusion 2 2 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of neladalkib.

  1. Nuvalent 2

Trials

2 of 2 trials shown

  1. Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

    Recruiting Phase 3 Nuvalent Started 2025Primary completion 2029-12 NCT06765109

    neladalkibalectinib FDA EU

    Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood

    ALK fusionNon-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive

  2. 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 Phase 1/2 Nuvalent Started 2022Primary completion 2027-12 NCT05384626

    neladalkibmidazolamRepaglinideitraconazole

    …y or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.

    ALK fusionLocally Advanced Solid Tumor, Metastatic Solid Tumor