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

Launched by NUVALENT INC. · May 17, 2022

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ClinConnect Summary

The clinical trial titled ALKOVE-1 is studying a new treatment called NVL-655 for patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors that have a specific genetic change known as ALK rearrangement or mutation. This study is looking to find out how safe NVL-655 is, the best dose to use, and how well it can help shrink tumors. The trial has two phases: the first phase focuses on safety and finding the right dose, while the second phase will measure how effective the treatment is in helping patients with their cancer.

To join the trial, participants must be at least 18 years old (or 12 years old and weigh more than 40 kg for a specific group), have a confirmed diagnosis of locally advanced or metastatic solid tumors with the ALK genetic change, and show that their cancer can be measured. They should also have functioning organs and bone marrow. However, people with certain other types of cancer mutations, allergies to the treatment components, recent major surgeries, or ongoing cancer therapies cannot participate. If eligible, participants can expect regular check-ups to monitor their health and response to the treatment throughout the study.

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Eligibility criteria

• 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.