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Back|NCT05384626Recruiting
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)

Phase
Phase 1/Phase 2
Sponsor
Nuvalent Inc.
Enrollment
840
Timeline
Jun 2022 → Jan 2028
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing \>40 kg.
  • 2Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
  • 3Phase 2
  • 4Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
  • 5Phase 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.
  • 6Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1 Phase 2: Must have measurable disease according to RECIST 1.1
  • 7Adequate organ function and bone marrow reserve

Exclusion Criteria

  • 1Patient's cancer has a known oncogenic driver alteration other than ALK.
  • 2Known allergy/hypersensitivity to excipients of NVL-655.
  • 3Major surgery within 4 weeks of the study entry
  • 4Ongoing or anticancer therapy
  • 5Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

Locations

74 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Ticiana Leal, MD

University of California Irvine Medical Center

Orange, California 92868

Recruiting

Misako Nagasaka, MD

University of California, Davis Comprehensive Cancer Center

Sacramento, California 95817

Recruiting

Jonathan Riess, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →