Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

Official Summary

This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 36 participants

Interventions

• PROCEDURE: Biopsy Procedure — Undergo biopsy
• PROCEDURE: Biospecimen Collection — Undergo collection of blood samples
• PROCEDURE: Echocardiography Test — Undergo ECHO
• PROCEDURE: Multigated Acquisition Scan — Undergo MUGA
• DRUG: Pidnarulex — Given IV

Primary Outcomes

• Maximum tolerated dose (dose escalation phase) (Up to completion of dose-escalation)
• Incidence of adverse events with drug combination at the recommended phase 2 dose (dose expansion phase) (Up to 3 years)

Secondary Outcomes

• Tumor response rate (Up to 3 years)
• Plasma concentrations of CX-5461 (pidnarulex) and trastuzumab deruxtecan (Cycle (C) 1 day (D) 1, C1D8, C1D10, C1D15, C2D1, C2D8, C2D10, C2D15 (cycle length = 21 days))
• Markers of deoxyribonucleic acid (DNA) damage repair (DDR) (At baseline and on-treatment)

Trial Locations

• Dana-Farber - Harvard Cancer Center LAO, Boston, Massachusetts, United States

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