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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia poniżej 2 w skali ECOG (pacjent może wykonywać większość codziennych czynności)
- •Liczba neutrofili co najmniej 1500/mcL (bez podawania czynników wzrostu w ciągu tygodnia przed badaniem)
- •Liczba płytek krwi co najmniej 100 000/mcL (bez transfuzji w ciągu tygodnia przed badaniem)
- •Parametry wątroby i krzepnięcia w normie lub nieznacznie podwyższone
- •Funkcja nerek wystarczająca (GFR co najmniej 60)
- •Co najmniej jedno poprzednie leczenie chemioterapią
- •Nowotwór z ekspresją białka HER2 (niski lub bardzo niski poziom) lub rak piersi wrażliwy na hormony
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 11, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Dana-Farber Cancer Institute
Boston, United States
Washington University School of Medicine
St Louis, United States
Trial contact
Site Public Contact
Filipa Lynce
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.