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RecruitingLast updated: 2 February 2024

ALKOVE-1: This phase I/II study is evaluating how safe, tolerable and effective a new cancer drug (NVL-655) is in people with advanced ALK-positive (ALK+) non-small cell lung cancer, and other solid cancersA Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Clinical summary

Summary

This study has two phases. Phase 1 (dose escalation) will determine the recommended phase 2 dose (RP2D) and, if applicable, maximum tolerated dose (MTD) of NVL-655 in people with ALK+ solid cancers. NVL-655 will be given daily via oral tablet. Phase 2 (dose expansion) will determine further assess the safety and effectiveness of NVL-655 and will consist of four cohorts. Cohort 2a will recruit people with ALK+ non-small cell lung cancer (NSCLC) who have received 1 prior 2nd generation ALK TKI (ceritinib, alectinib, brigatinib). Cohort 2b will recruit people with ALK+ NSCLC who have received 2-3 prior 1st or 2nd-generation ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib). Cohort 2c will recruit people with ALK+ NSCLC who have received 2-3 prior ALK TKIs, with lorlatinib in the 2nd or 3rd line. Cohort 2d will recruit people with ALK+ solid cancers, including people with NSCLC who are not eligible for cohorts 2a-c, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.

Conditions

This trial is treating patients with ALK-positive (ALK+) advanced solid cancers, including non-small cell lung cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People12+

Phase

I/II

Trial Acronym

ALKOVE-1

More information

Trial Identifiers

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Trial sponsor

Nuvalent Inc.

Scientific Title

A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Eligibility

Inclusion

  1. Age ≥18 years Phase 2 Cohort 2d 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. Cohorts 2a, 2b, and 2c: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
    2. Cohort 2d: histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation
  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

  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.

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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