Overview

ATI-2231 With in Advanced Solid Tumor Malignancies Followed by ATI-2231 in Combination With Capecitabine in Patients With Hormone Receptor-positive and HER2 Negative Metastatic Breast Cancer

Status:
Not yet recruiting

Trial end date:
2030-10-01

Target enrollment:

Participant gender:

Summary

Phase Ia is a dose-escalation Phase I study of ATI-2231 monotherapy, using 3 plus 3 design, with the primary endpoint of adverse events. Phase Ib tests the safety and tolerability of ATI-2231 in combination with chemotherapy (capecitabine) at recommended phase II dose (RP2D) obtained from Phase Ia. This is followed by the randomized Phase II study of ATI-2231 in combination with chemotherapy testing the hypothesis that the combination of chemotherapy (capecitabine) and ATI-2231 will reduce bone turnover, improve clinical efficacy including progression-free survival (PFS), improve patient bone density and patient quality of life.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Washington University School of Medicine

Collaborators:

Aclaris Therapeutics, Inc.
United States Department of Defense

Treatments:

Capecitabine
Denosumab
Diphosphonates