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NCT05384626 · ClinicalTrials.gov registry record · Phase 1
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
A Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Nuvalent.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 840
- Enrollment target
- 20
- Study locations
NCT05384626: Recruiting Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Nuvalent.
NCT05384626 is a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor that is actively recruiting participants, run by Nuvalent. The registered enrollment target is 840 participants, above the 176-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (377% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05384626, a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, is actively recruiting participants, sponsored by Nuvalent.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 840 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib 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 neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors.
Primary Outcome
Define the dose limiting toxicities (DLTs)
Conditions Studied
Interventions
- DRUG Neladalkib (NVL-655)
Study Locations (20)
California
- University of California Irvine Medical Center - Orange
- University of California, Davis Comprehensive Cancer Center - Sacramento
- Stanford Cancer Institute - Stanford
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York
- Memorial Sloan Kettering Cancer Center - New York
Colorado
- University of Colorado Cancer Center - Aurora
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- University of Miami; Sylvester Cancer Center - Miami
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
What NCT05384626 shows while recruiting
NCT05384626 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, above the 176-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (377% higher).
The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which Neladalkib (NVL-655) is the first listed.
NCT05384626 names 20 study sites across 16 states, led by California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT05384626 about?
NCT05384626 is a clinical study titled "A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)". 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 evalu...
What is the current status of trial NCT05384626?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 840 participants. The study started on 2022-06-09. Estimated completion is 2028-01.
What conditions does trial NCT05384626 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, Locally Advanced Solid Tumor.
What interventions are being tested in trial NCT05384626?
The interventions under investigation include: Neladalkib (NVL-655) (DRUG).
Who is sponsoring clinical trial NCT05384626?
This trial is sponsored by Nuvalent, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05384626 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05384626's enrollment target sits among peer trials
840 1st of 52 higher than 52 of 52 other Metastatic Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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