ActiveCancerNIHR-supported projectDigestion, Kidneys & Other Organs
HERTHENA-Pan Tumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecam (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors.
Recipient organisationNIHR Barts Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodJan 2025 — Feb 2029
In plain English
AI plain-English summary
A new drug called patritumab deruxtecan is being tested in roughly 400 patients whose advanced solid tumours have stopped responding to all available treatments. This matters because many cancers—including lung, breast, and colorectal—carry a protein called HER3 on their surface, but no drug has yet been approved that targets it. The study drug is an antibody-drug conjugate: one part locks onto HER3 on tumour cells, the other delivers a chemotherapy payload directly inside them. The trial is designed to find out whether this approach can shrink tumours or slow their growth in patients who have run out of options. If the drug works, it could become a new treatment for multiple cancer types that share the HER3 marker, offering a targeted therapy where none currently exists. The study is also testing tumour tissue for biomarkers that might predict which patients are most likely to benefit, which could guide future treatment decisions. The trial runs for about 27 months across roughly 100 global sites, including in the UK.
View original technical description
This is a Phase 2, Multicohort, Open-Label study looking to learn more about drug called patritumab deruxtecan (HER3-DXd; U3-1402) in patients diagnosed with cancer that is unable to be surgically removed or has spread from its main location to other parts of your body and has progressed on currently available therapies. HER3-DXd is a type of drug called an antibody drug conjugate (ADC) made to attach to tumour cells to deliver chemotherapy directly to the tumour cells. The purpose of the study is to see if HER3-DXd can improve the participant’s cancer and to evaluate the possible side-effects of this drug.The study is divided into 4 periods: 1. Screening period – will determine if the participant meets the requirements to take part in the study. Will be a maximum of 35 days.2. The Tumour Tissue Screening Period- The Sponsor will collect a sample of tumour tissue, to test the for certain biomarkers. This will occur at the same time as the Screening Period.3. Treatment period- HER3-DXd is given into a vein ( intravenously) every 3 weeks.4. Follow-up Period- patients will have a visit immediately after stopping the drug HER3-DXd and a Safety Follow-up visit 40days after stopping the drug. A period called efficacy assessment follow up will begin in case the patient stopped the study drug for any other reason than progression of the disease, imaging scans will be performed to measure changes in location, number, and size of any tumours until there is evidence that the disease has worsened. After the completion of the Efficacy Assessment Follow-up Period, they will enter the long-term survival follow up (LTSFU) and will be contacted at least once every 3 months to follow up with their health status, and document any other anticancer treatment.The anticipated total duration of the study for each cohort is approximately 27 months. The study will be carried out at approximately 100 sites globally and across the UK and aims to recruit approximately 400 patients.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know