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

Inclusion Criteria:

   1. Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing >40 kg.

   2. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic
   solid tumor with a documented ALK rearrangement or activating ALK mutation.

   3. Phase 2

      1. Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally
      advanced or metastatic NSCLC with a documented ALK rearrangement

      2. Phase 2 Cohort 2f: Histologically or cytologically confirmed locally advanced or
      metastatic solid tumor with a documented ALK rearrangement or activating ALK
      mutation detected by certified assay.

   4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1
   Phase 2: Must have measurable disease according to RECIST 1.1

   5. Adequate organ function and bone marrow reserve

Exclusion criteria:

   1. Patient's cancer has a known oncogenic driver alteration other than ALK.

   2. Known allergy/hypersensitivity to excipients of NVL-655.

   3. Major surgery within 4 weeks of the study entry

   4. Ongoing or anticancer therapy

   5. Actively receiving systemic treatment or direct medical intervention on another
   therapeutic clinical study.