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

Sai-Hong Ignatius Ou


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:

Eligibility

Adult

Interested in joining this trial?

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.

Get in touch with our study team