Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

Summary

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.

Official 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)

Details

In Phase 2, study patients will be enrolled into 4 distinct cohorts: - Cohort 2a: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, brigatinib) - Cohort 2b: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior 1st or 2nd-generation ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib) - Cohort 2c: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs, with lorlatinib in the 2nd or 3rd line - Cohort 2d: Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, including patients with NSCLC not eligible for cohorts 2a-c, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists

Keywords

Locally Advanced Solid Tumor Metastatic Solid Tumor Neoplasms NVL-655

Eligibility

You can join if…

Open to people ages 12 years and up

  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
  4. Cohorts 2a, 2b, and 2c: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
  5. Cohort 2d: histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation
  6. 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

  1. Adequate organ function and bone marrow reserve

You CAN'T join if...

  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.

Locations

  • University of California Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • University of Colorado Cancer Center not yet accepting patients
    Denver Colorado 80045 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Nuvalent Inc.
ID
NCT05384626
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 214 study participants
Last Updated