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NCT05384626 | RECRUITING | Locally Advanced Solid Tumor

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

Nuwalnt Inch.

Brief 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 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.

Condition or disease

Locally Advanced Solid Tumor

Metastatic Solid Tumor

Intervention/treatment

NVL-655

Phase

PHASE1

PHASE2

Detailed Description:

In Phase 2, study patients will be enrolled into 6 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, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. * Cohort 2b: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. * Cohort 2c: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed. * Cohort 2d: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed. * Cohort 2e: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts. * Cohort 2f: Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.

Study Type : INTERVENTIONAL
Estimated Enrollment : 470 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2022-06-09
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
  • Exclusion criteria
    • 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.
A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

Location Details

NCT05384626

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California Irvine Medical Center

Orange, California, United States, 92868

RECRUITING

United States, California

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

RECRUITING

United States, California

Stanford Cancer Institute

Stanford, California, United States, 94305

RECRUITING

United States, Colorado

University of Colorado Cancer Center

Denver, Colorado, United States, 80045

RECRUITING

United States, District of Columbia

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

RECRUITING

United States, Florida

University of Miami; Sylvester Cancer Center

Miami, Florida, United States, 33136

RECRUITING

United States, Georgia

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

RECRUITING

United States, Maryland

John Hopkins University

Baltimore, Maryland, United States, 21224

RECRUITING

United States, Massachusetts

Mass General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Henry Ford Cancer Institute

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

Washington University School of Medicine Siteman Cancer Center

Saint Louis, Missouri, United States, 63310

RECRUITING

United States, New York

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, Ohio

OSU Brain & Spine Hospital

Columbus, Ohio, United States, 43210

RECRUITING

United States, Pennsylvania

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Tennessee

Sarah Cannon

Nashville, Tennessee, United States, 37203

ACTIVE NOT RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

RECRUITING

Australia, New South Wales

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia, 2065

RECRUITING

Australia, Queensland

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

RECRUITING

Australia, Victoria

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

RECRUITING

Belgium,

University hospitals Leuven Campus Gasthuisberg

Leuven, Belgium, 3000

RECRUITING

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

RECRUITING

Canada, Ontario

The Ottawa Hospital Cancer Center

Ottawa, Ontario, Canada, K1h 8l6

RECRUITING

Canada, Ontario

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 0a3

RECRUITING

Canada,

BC Cancer

Vancouver, Canada, VZ 4E6

RECRUITING

France,

Center Leon Berard

Lyon, France, 69373

RECRUITING

France,

chu den antes

Saint-Herblain, France, 44800

RECRUITING

France,

Institut Claudius Regaud

Toulouse Cedex, France, 31059

RECRUITING

France,

Gustave Roussy Institute

Villejuif, France, 94805

RECRUITING

Germany,

Universitate Clinic Koln - University Hospital Cologne

Cologne, Germany,

RECRUITING

Germany,

LungenClinic Grosshansdorf GmbH

Grosshansdorf, Germany,

RECRUITING

Germany,

Universkitatsklinikum Heidelberg - University Hospital Heidelberg

Heidelberg, Germany,

RECRUITING

Italy,

University Hospital Hospital Riuniti Umberto

Ancona, Italy,

RECRUITING

Italy,

IRCCS "G. Paolo II" Cancer Institute

Bari, Italy, 70124

RECRUITING

Italy,

European Institute of Oncology

Milano, Italy, 20141

RECRUITING

Italy,

IRCCS Foundation National Cancer Institute

Milan, Italy,

RECRUITING

Italy,

Santa Maria delle Croci Hospital

Ravenna, Italy, 48121

RECRUITING

Italy,

Regina Elena Institute for Cancer Research

Rome, Italy, 00144

RECRUITING

Italy,

Veneto Oncological Institute

Veneto, Italy,

RECRUITING

Japan,

Okayama University Hospital

Okayama, Japan,

RECRUITING

Japan,

Kindai University Hospital

Osaka, Japan, 5898511

RECRUITING

Japan,

National Cancer Center Hospital

Tokyo, Japan, 1040045

RECRUITING

Japan,

Center Institute Hospital of JFCR

Tokyo, Japan, 1358550

RECRUITING

Japan,

Wakayama Medical University Hospital

Wakayama, Japan,

RECRUITING

Korea, Republic of, Ravy

National Cancer Center

Shaky, Gyeongggi-do, Korea, Republic of, 10408

RECRUITING

Korea, Republic of, Seoul Capital

Seoul National University Hospital

Seoul, Seoul Capital, Korea, Republic of, 03080

RECRUITING

Korea, Republic of, Seoul Capital

Severance Hospital Yonsei University Health System

Seoul, Seoul Capital, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of, 06351

RECRUITING

Netherlands,

The Netherlands Cancer Institute

Amsterdam, Netherlands, 1066 CX

RECRUITING

Netherlands,

University Medical Center Groningen (UMCG)

Groningen, Netherlands, 9713

RECRUITING

Singapore,

National University Hospital

Singapore, Singapore, 119074

RECRUITING

Singapore,

National Cancer Centre Singapore

Singapore, Singapore, 168583

RECRUITING

Spain,

University Hospital Complex of A Coruna

A Coruña, Spain, 15006

RECRUITING

Spain,

UOMI Cancer Center

Barcelona, Spain, 08017

RECRUITING

Spain,

Vall d'Hebron

Barcelona, Spain, 08035

RECRUITING

Spain,

Gregorio Maranon University General Hospital

Madrid, Spain, 28007

RECRUITING

Spain,

October 12 University Hospital

Madrid, Spain, 28041

RECRUITING

Switzerland,

Italian Switzerland Oncology Institute

Bellinzona, Switzerland,

RECRUITING

Switzerland,

Lucerne Cantonal Hospital

Spitalstrasse, Switzerland,

RECRUITING

Taiwan,

Chung-Shan Medical University Hospital

Taichung City, Taiwan,

RECRUITING

Taiwan,

National Cheng If University Hospital

Tainan, Taiwan, 70403

RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 100

RECRUITING

United Kingdom, Surrey

Royal Marsden Hospital

Suton, Surrey, United Kingdom, SM2 5pt

RECRUITING

United Kingdom,

Edinburgh Cancer Centre

Edinburgh, United Kingdom, EH4 2XU

RECRUITING

United Kingdom,

The Royal Marsden - Chelsea

London, United Kingdom,

RECRUITING

United Kingdom,

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX