Evaluating NVL-655 for Advanced ALK-Positive Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a Phase 1/2 study designed to assess the safety and tolerability of NVL-655 in patients with advanced solid tumors that have an ALK rearrangement or activating ALK mutation. The trial will involve a dose escalation phase to determine the recommended dose for further testing, followed by an expansion phase to evaluate the drug's effectiveness in various cohorts of patients with ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. Key outcomes include the objective response rate, duration of response, and overall survival among participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing \>40 kg. DDI sub-study Cohorts G and H only: age 18-60 years, inclusive
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. DDI sub-study cohorts: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
5. DDI sub-study cohorts: Must have previously received ≥1 ALK TKI; no prior investigational agents targeting ALK; any number of prior chemotherapy and/or immunotherapy
6. 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
7. 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.

Where it's running

• University of California Irvine Medical Center
  Orange, California, United States Recruiting
• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Stanford Cancer Institute
  Stanford, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• Georgetown University Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• University of Miami; Sylvester Cancer Center
  Miami, Florida, United States Recruiting

+24 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Nuvalent Clinical Trial
• Email: clinicaltrials@nuvalent.com
• Phone: 857-357-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.