Phase 2 Study of HER3-DXd in Locally Advanced or Metastatic Solid Tumors
Research type
Research Study
Full title
HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors.
IRAS ID
1009782
Contact name
Bettina Steffens
Contact email
Sponsor organisation
Daiichi Sankyo Inc.
Clinicaltrials.gov Identifier
Research summary
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.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0155
Date of REC Opinion
22 Aug 2024
REC opinion
Further Information Favourable Opinion