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A Study of ALRN-6924 for Protection of Chemotherapy-Induced Side Effects in Patients With TP53-Mutant Breast Cancer

NCT05622058 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-02-27

No results posted yet for this 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.

Conditions

  • Prevention of Chemotherapy-induced Myelosuppression

Interventions

DRUG

ALRN-6924

ALRN-6924 administered in every chemotherapy treatment cycle as an IV infusion over 1 hour on Days 0 (approximately 18 hours prior to chemotherapy administration), 1 (approximately 1 hour prior to chemotherapy administration), and 2 (approximately 24 hours after the second infusion of ALRN-6924).

DRUG

TAC (doxorubicin 50 mg/m2; cyclophosphamide 500 mg/m2; docetaxel 75 mg/m2)

TAC will be administered as an IV infusion on Day 1 of every 3-week treatment cycle

Sponsors & Collaborators

  • Aileron Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2023-02-22
Completion
2023-02-22
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Bulgaria
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622058 on ClinicalTrials.gov