A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mu… (NCT05622058) | Clinical Trial Compass
TerminatedPhase 1
A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer
Stopped: The study has been terminated early given that the first four patients enrolled have experienced Grade 4 neutropenia and alopecia after cycle 1 and as such failed to meet the primary endpoint and the main secondary endpoint.
United States, Bosnia and Herzegovina, Bulgaria6 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Females and males, age ≥18years.
* Patients who, in the investigator's judgment, are able to understand and willing to comply with the requirements of this clinical trial and to provide written informed consent.
* Histologically confirmed diagnosis of HER2 negative breast cancer
* Candidate to receive chemotherapy with TAC regimen
* Presence of p53 mutation(s) in tumor tissue as assessed by next generation sequencing (NGS).
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
* Left ventricular ejection fraction \> 55%.
* Laboratory results obtained within 14 days prior to the first study treatment administration (Cycle 1, Day 0) demonstrating:
* Absolute neutrophil count (ANC) ≥ 1500 cells/μL (without granulocyte colony stimulating factor \[G-CSF\] support within 2 weeks prior to the first study treatment administration)
* Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to the first study treatment administration)
* Hemoglobin ≥ 10.0 g/dL
* AST, ALT, and alkaline phosphatase ≤ 2.5 x the upper limit of normal (ULN)
* Serum bilirubin ≤ 1.5× ULN (patients with known Gilbert's disease who have serum bilirubin level ≤ 3× ULN may be enrolled.)
* Patients who are not receiving therapeutic anticoagulation: Calculated creatinine clearance (CrCl) ≥ 30 mL/min (Cockcroft-Gault formula).
* Have not received prior chemotherapy or targeted systemic therapy for their breast cancer.
Exclusion Criteria:
* Known hypers…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of ALRN-6924 in combination with TAC chemotherapy
Timeframe: Approximately 24 weeks
2
Chemoprotective effects of ALRN-6924 on bone marrow toxicities