Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sai-Hong Ou, MD, PhD

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 accepting new patients
    Orange California 92868 United States
  • University of Colorado Cancer Center accepting new patients
    Denver Colorado 80045 United States

Lead Scientist at UC Irvine

  • Sai-Hong Ou, MD, PhD
    Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 6 research publications

Details

Status
accepting new patients
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