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 States6 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 range18 Years

SexALL

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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…

What they're measuring

Safety and tolerability of ALRN-6924 in combination with TAC chemotherapy

Timeframe: Approximately 24 weeks

Chemoprotective effects of ALRN-6924 on bone marrow toxicities

Timeframe: Approximately 3 weeks for each patient

Trial details

NCT IDNCT05622058

SponsorAileron Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-22