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Ph I/II Study of NVL-655 Patients with Advanced NSCLC and Other Solid Tumors

Misako Nagasaka

A Study On:

  • Small Intestine
  • Other Respiratory and Intrathoracic Organs
  • Soft Tissue
  • Mycosis Fungoides
  • Ovary
  • Colon
  • Larynx
  • Lung
  • Other Female Genital
  • Lip, Oral Cavity and Pharynx
  • Pancreas
  • Urinary Bladder
  • Brain and Nervous System
  • Breast
  • Rectum
  • Anus
  • Prostate
  • Kidney
  • Melanoma, Skin
  • Kaposi's Sarcoma
  • Esophagus
  • Thyroid
  • Unknown Sites
  • Stomach
  • Other Digestive Organ
  • Bones and Joints
  • Cervix
  • Corpus Uteri
  • Other Urinary
  • Liver
  • Other Skin
  • Other Male Genital
  • Eye and Orbit
  • Other Endocrine System
  • Ill-Defined Sites

Status:

  • Open

Eligibility

Adult

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Official Title

A Phase I/II Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Details

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.

Eligibility

You can join if...

Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; your study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study.

Inclusion Criteria:

  1. Age = or > 18 years
  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
    a. Cohorts 2a, 2b, and 2c: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
    b. Cohort 2d: histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation
  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.

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