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NCT06521554 · ClinicalTrials.gov registry record · Phase 1
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)
A Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Nuvalent.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06521554: Recruiting Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Nuvalent.
NCT06521554 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 200 participants, roughly in line with the 188-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target. The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06521554, 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
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.
Primary Outcome
To determine up to 2 RP2D Candidates
Conditions Studied
Interventions
- DRUG NVL-330
Study Locations (20)
California
- City of Hope - Lennar - Irvine
- University of California, Davis Comprehensive Cancer Center - Sacramento
- Stanford Cancer Institute - Stanford
District of Columbia
- Georgetown University Medical Center - Washington D.C.
- Sibley Memorial Hospital - Washington D.C.
New South Wales
- Chris O'Brien Lifehouse - Camperdown
- North Shore Health Hub - Saint Leonards
Colorado
- Sarah Cannon Research Institute at HealthONE - Denver
Florida
- Sylvester Comprehensive Cancer Center - Miami
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bayview Medical Center - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Henry Ford Cancer Center - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-07-18 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT06521554 shows while recruiting
NCT06521554 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 188-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target.
The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which NVL-330 is the first listed.
NCT06521554 names 20 study sites across 16 states, led by California, District of Columbia, New South Wales.
Frequently Asked Questions
What is clinical trial NCT06521554 about?
NCT06521554 is a clinical study titled "A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)". Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-sma...
What is the current status of trial NCT06521554?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2024-07-18. Estimated completion is 2027-02.
What conditions does trial NCT06521554 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, Locally Advanced Solid Tumor.
What interventions are being tested in trial NCT06521554?
The interventions under investigation include: NVL-330 (DRUG).
Who is sponsoring clinical trial NCT06521554?
This trial is sponsored by Nuvalent, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06521554 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06521554's enrollment target sits among peer trials
200 18th of 52 higher than 35 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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