OncRef

Clinical Trial: NCT03725436

ALRN-6924 and Paclitaxel in Treating Patients With Advanced, Metastatic, or Unresectable Solid Tumors

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:M.D. Anderson Cancer Center
Information Provided By:M.D. Anderson Cancer Center
Last Update Posted:2026-03-16

Study Overview

Brief Summary

This phase Ib trial studies the side effects and best dose of ALRN-6924 when given together with paclitaxel in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ALRN-6924 and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Official Title

A Phase 1b Study of ALRN-6924 in Combination With Paclitaxel in Wild-Type TP53 Advanced or Metastatic Solid Tumors Including Estrogen-Receptor Positive Breast Cancer

Conditions

Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Metastatic Malignant Solid Neoplasm, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Recurrent Breast Carcinoma, TP53 wt Allele, Unresectable Malignant Solid Neoplasm

Intervention / Treatment

  • Drug: MDM2/MDMX Inhibitor ALRN-6924
  • Drug: Paclitaxel

Other Study ID Numbers

  • 2018-0561
  • NCI-2018-02192
  • 2018-0561

Start Date (Actual)

2019-01-24

Primary Completion Date (Actual)

2026-03-11

Study Completion Date (Actual)

2026-03-11

Enrollment (Actual)

28

Study Type

Interventional

Phase

Phase 1