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NCT05580770 · ClinicalTrials.gov registry record · Phase 1
Mirdametinib + BGB-3245 in Advanced Solid Tumors
A Phase 1 study, sponsored by SpringWorks Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT05580770: Clinical Trial Phase 1 study, sponsored by SpringWorks Therapeutics.
NCT05580770 is a Phase 1 study that was terminated before completion, run by SpringWorks Therapeutics. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05580770, a Phase 1 study, was terminated before completion, sponsored by SpringWorks Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.
Primary Outcome
Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs). TEAE severities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. AEs were coded using MedDRA Version 27.1.
Interventions
- DRUG Mirdametinib 2mg
- DRUG BGB-3245 5mg
- DRUG Mirdametinib 3mg
- DRUG Mirdametinib 4mg
- DRUG BGB-3245 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-02-03 |
| Est. Completion | 2025-01-15 |
| Phase | Phase 1 |
Why NCT05580770 stopped before completion
NCT05580770 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Mirdametinib 2mg is the first listed.
NCT05580770 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05580770 about?
NCT05580770 is a clinical study titled "Mirdametinib + BGB-3245 in Advanced Solid Tumors". A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory ...
What is the current status of trial NCT05580770?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2023-02-03. Estimated completion is 2025-01-15.
What interventions are being tested in trial NCT05580770?
The interventions under investigation include: Mirdametinib 2mg (DRUG), BGB-3245 5mg (DRUG), Mirdametinib 3mg (DRUG), Mirdametinib 4mg (DRUG), BGB-3245 10mg (DRUG).
Who is sponsoring clinical trial NCT05580770?
This trial is sponsored by SpringWorks Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05580770's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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