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
Public ClinicalTrials.gov record NCT07137416. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors
Study identification
- NCT ID
- NCT07137416
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- Enrollment
- 36 participants
Conditions and interventions
Conditions
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Invasive Breast Carcinoma
- Locally Advanced Breast Carcinoma
- Metastatic Breast Carcinoma
- Metastatic HER2-Low Breast Carcinoma
- Metastatic HER2-Positive Breast Carcinoma
- Metastatic Hormone Receptor-Positive Breast Carcinoma
- Metastatic Malignant Solid Neoplasm
- Metastatic Triple-Negative Breast Carcinoma
- Unresectable Breast Carcinoma
- Unresectable HER2-Low Breast Carcinoma
- Unresectable HER2-Positive Breast Carcinoma
- Unresectable Hormone Receptor-Positive Breast Carcinoma
- Unresectable Malignant Solid Neoplasm
- Unresectable Triple-Negative Breast Carcinoma
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Echocardiography Test Procedure
- Multigated Acquisition Scan Procedure
- Pidnarulex Drug
- Radiologic Imaging Procedure Procedure
- Trastuzumab Deruxtecan Biological
Procedure · Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 4, 2026
- Primary completion
- Jan 9, 2028
- Completion
- Jan 9, 2028
- Last update posted
- May 12, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dana-Farber - Harvard Cancer Center LAO | Boston | Massachusetts | 02115 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07137416, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 12, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07137416 live on ClinicalTrials.gov.