NCT07137416View on ClinicalTrials.gov

Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

December 9, 2025

Primary Completion Date

March 9, 2027

Study Completion Date

March 9, 2027

Conditions
Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Invasive Breast CarcinomaLocally Advanced Breast CarcinomaMetastatic Breast CarcinomaMetastatic HER2-Low Breast CarcinomaMetastatic HER2-Positive Breast CarcinomaMetastatic Hormone Receptor-Positive Breast CarcinomaMetastatic Malignant Solid NeoplasmMetastatic Triple-Negative Breast CarcinomaUnresectable Breast CarcinomaUnresectable HER2-Low Breast CarcinomaUnresectable HER2-Positive Breast CarcinomaUnresectable Hormone Receptor-Positive Breast CarcinomaUnresectable Malignant Solid NeoplasmUnresectable Triple-Negative Breast Carcinoma
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

PROCEDURE

Radiologic Imaging Procedure

Undergo radiologic imaging

BIOLOGICAL

Trastuzumab Deruxtecan

Given IV

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH