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

Description

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 evaluate the overall safety and tolerability of NVL-655 and 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.

Conditions

Locally Advanced Solid Tumor, Metastatic Solid Tumor

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Study Overview

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Study Details

Study overview

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 evaluate the overall safety and tolerability of NVL-655 and 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.

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)

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

Condition
Locally Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine Medical Center, Orange, California, United States, 92868

Sacramento

University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States, 95817

Stanford

Stanford Cancer Institute, Stanford, California, United States, 94305

Denver

University of Colorado Cancer Center, Denver, Colorado, United States, 80045

Washington

Georgetown University Medical Center, Washington, District of Columbia, United States, 20007

Miami

University of Miami; Sylvester Cancer Center, Miami, Florida, United States, 33136

Atlanta

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States, 30322

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Baltimore

John Hopkins University, Baltimore, Maryland, United States, 21224

Boston

Mass General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥18 years, Phase 2 Cohort 2f 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. Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
  • 2. 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.
  • 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
  • 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.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nuvalent Inc.,

Viola Zhu, MD, PHD, STUDY_DIRECTOR, Nuvalent Inc.

Study Record Dates

2026-03