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NCT05907304 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Erasca.
- Active
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 20
- Study locations
NCT05907304: Active Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Erasca.
NCT05907304 is a Phase 1 study of Advanced or Metastatic Solid Tumors that is active but no longer recruiting, run by Erasca. The registered enrollment target is 86 participants, below the 232-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05907304, a Phase 1 study of Advanced or Metastatic Solid Tumors, is active but no longer recruiting, sponsored by Erasca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors * To evaluate the safety and tolerability of naporafenib administered with trametinib in patients with RAS Q61X solid tumors * To characterize the pharmacokinetic (PK) profile of naporafenib and trametinib when administered to patients with RAS Q61X solid tumors
Primary Outcome
Based on assessment of Objective response rate (ORR) per RECIST version 1.1
Conditions Studied
Interventions
- DRUG Trametinib
- DRUG Naporafenib
Study Locations (20)
Florida
- Florida Cancer Specialists - Sarasota - Sarasota
- Florida Cancer Specialists - St. Petersburg - St. Petersburg
Virginia
- Inova Schar Cancer Institute - Fairfax
- NEXT Virginia - Fairfax
California
- University of California, San Francisco - San Francisco
Connecticut
- Yale Cancer Center - New Haven
Georgia
- Emory University School of Medicine - Atlanta
Michigan
- Henry Ford Health System - Detroit
Missouri
- Washington University School of Medicine - St Louis
Nevada
- Comprehensive Cancer Center of Nevada (CCCN) - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT05907304 still lists
NCT05907304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 232-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Trametinib is the first listed.
NCT05907304 names 20 study sites across 18 states, led by Florida, Virginia, California.
Frequently Asked Questions
What is clinical trial NCT05907304 about?
NCT05907304 is a clinical study titled "A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations". To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors * To evaluate the safety and tolerability of naporafenib administered with trametinib in patients with RAS Q61X solid tumors * To characterize the pharmacokinetic...
What is the current status of trial NCT05907304?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2023-08-17. Estimated completion is 2026-12.
What conditions does trial NCT05907304 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT05907304?
The interventions under investigation include: Trametinib (DRUG), Naporafenib (DRUG).
Who is sponsoring clinical trial NCT05907304?
This trial is sponsored by Erasca, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05907304 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05907304's enrollment target sits among peer trials
86 18th of 19 higher than 2 of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors 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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