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NCT05622058 · ClinicalTrials.gov registry record · Phase 1
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
A Phase 1 study, sponsored by Aileron Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05622058: Clinical Trial Phase 1 study, sponsored by Aileron Therapeutics.
NCT05622058 is a Phase 1 study that was terminated before completion, run by Aileron Therapeutics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05622058, a Phase 1 study, was terminated before completion, sponsored by Aileron Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are not dividing may be spared from chemotherapy damage and the patient should have less side effects.
Primary Outcome
Proportion of patients with Common Terminology Criteria for Adverse Events (CTCAE) Grade 3/4 treatment emergent adverse events (TEAEs); proportion of patients with treatment-related adverse events and serious adverse events as assessed by NCI CTCAE v5.0 Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). System Organ Class (SOC) and Preferred Term (PT) will be attached to the clinical database. AE severity will be graded us
Interventions
- DRUG ALRN-6924
- DRUG TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2023-02-22 |
| Phase | Phase 1 |
Why NCT05622058 stopped before completion
NCT05622058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which ALRN-6924 is the first listed.
NCT05622058 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05622058 about?
NCT05622058 is a clinical study titled "A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer". This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects ce...
What is the current status of trial NCT05622058?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2023-01-09. Estimated completion is 2023-02-22.
What interventions are being tested in trial NCT05622058?
The interventions under investigation include: ALRN-6924 (DRUG), TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2) (DRUG).
Who is sponsoring clinical trial NCT05622058?
This trial is sponsored by Aileron Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05622058's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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