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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07137416
Phase
PHASE1
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Pidnarulex — DRUG
    Given IV
  • Radiologic Imaging Procedure — PROCEDURE
    Undergo radiologic imaging
  • Trastuzumab Deruxtecan — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 5, 2026
Status verified
May 2026
Primary completion
Jan 10, 2028
Completion
Jan 10, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Pidnarulex, T-DXd)
    Patients receive pidnarulex IV over 60 minutes on day 8 of each cycle and T-DXd IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA, collection of blood samples, and radiologic imaging throughout the trial. Patients may also undergo biopsy throughout the trial.

Primary Outcome Measure

Maximum tolerated dose (dose escalation phase) [ Time Frame: Up to completion of dose-escalation ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Site Public Contact
877-442-3324
Filipa Lynce (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAWashington University School of Medicine· St Louis, MO

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