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

Recruiting now · Phase 1/Phase 2

Conditions studied: Locally Advanced Solid Tumor, Metastatic Solid Tumor

In brief

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (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 evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib 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 neladalkib 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 neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors. A drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC

Key facts

Study ID

NCT05384626

Run by

Nuvalent Inc.

People needed

840

Starts

2022-06-09

Expected to finish

2028-01-01

Last updated by the study team

2026-05-27

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing >40 kg. DDI sub-study Cohorts G and H only: age 18-60 years, inclusive
• Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
• Phase 2
• Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
• 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.
• DDI sub-study cohorts: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
• DDI sub-study cohorts: Must have previously received ≥1 ALK TKI; no prior investigational agents targeting ALK; any number of prior chemotherapy and/or immunotherapy
• 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
• Adequate organ function and bone marrow reserve

You may not qualify if…

• Patient's cancer has a known oncogenic driver alteration other than ALK.
• Known allergy/hypersensitivity to excipients of NVL-655.
• Major surgery within 4 weeks of the study entry
• Ongoing or anticancer therapy
• Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

Where it is running

• University of California Irvine Medical Center — Orange, California, United States (enrolling)
• Stanford Cancer Institute — Stanford, California, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• University of Miami; Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• John Hopkins University — Baltimore, Maryland, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Cancer Institute — Detroit, Michigan, United States (enrolling)
• Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• OSU Brain & Spine Hospital — Columbus, Ohio, United States (enrolling)
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• Sarah Cannon — Nashville, Tennessee, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Royal North Shore Hospital — Sydney, New South Wales, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (enrolling)
• Universitair Ziekenhuis Antwerpen (UZA) — Antwerp, Belgium (enrolling)
• Universitaire Ziekenhuizen Leuven Campus Gastthuisberg — Leuven, Belgium (enrolling)

Full record on ClinicalTrials.gov

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