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New treatment option for Locally Advanced Solid Tumor
Official title A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
ClinicalTrials.gov ID: NCT05384626
What this study is testing
What is Neladalkib (NVL-655)?
Neladalkib (NVL-655) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for locally advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (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 neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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
- Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK...
- Phase 2
- Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
- Phase 2 Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or...
You likely can't join if
- Patient's cancer has a known oncogenic driver alteration other than ALK.
- Known allergy/hypersensitivity to excipients of NVL-655.
- Major surgery within 4 weeks of the study entry
- Ongoing or anticancer therapy
- Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
See the full eligibility criteria
- 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
- Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
- Phase 2
- Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
- 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.
- DDI sub-study cohorts: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
- 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
- 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
- Adequate organ function and bone marrow reserve
- Patient's cancer has a known oncogenic driver alteration other than ALK.
- Known allergy/hypersensitivity to excipients of NVL-655.
- Major surgery within 4 weeks of the study entry
- Ongoing or anticancer therapy
- Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Sacramento, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Sydney, New South Wales, Australia
+ 45 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Sacramento, California, United States; Stanford, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States and 59 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.