Clinical trial 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)?
an investigational oral tablet being studied as a potential treatment for locally advanced solid tumors, including ALK‑positive non‑small cell lung cancer is designed to block the activity of the ALK protein, which can drive tumor growth
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
- The study aims to find a safe dose of neladalkib and see how well it works against tumors that have an ALK change. It also looks at how long any tumor shrinkage lasts and overall survival.
- Who it's for
- Adults whose cancer is advanced, has spread, and tests positive for an ALK rearrangement or mutation.
- What's involved
- Participants will take the study drug, have regular clinic visits, blood draws, and imaging scans to check tumor size. Some may also take other medicines to study drug interactions.
- Time commitment
- The trial runs for several months, with visits every few weeks for dosing and safety checks, plus periodic scans.
- 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 is enrolling
- 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
- Seattle, Washington, United States
- Sydney, New South Wales, Australia
- Woolloongabba, Queensland, Australia
+ 44 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, but 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?
This study is enrolling now at 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 58 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.