Dose escalation and expansion study of SAR443216 in patients with relapsed/refractory HER2 tumors
Research type
Research Study
Full title
A Phase 1/1b open-label, first-in-human, single agent, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SAR443216 in participants with relapsed/refractory HER2 expressing solid tumors.
IRAS ID
1008758
Contact name
Oleksandra Chudnivets
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2021-000086-32
Clinicaltrials.gov Identifier
Research summary
The sponsor is testing a new medicine SAR443216 in patients with advanced stage cancer expressing human epidermal growth factor receptor 2 (HER2) cells. SAR443216 is an antibody. An antibody is a protein produced in the blood to fight diseases by attacking and killing foreign organisms such as bacteria and viruses, and also attacking and killing cancer cells. SAR443216 has shown an ability to reduce tumor growth when tested in animals, where it has also shown some side effects in animal studies. The effects of administering SAR443216 in humans, both good and bad, are being studied in this clinical study. UK is taking part in part 2 of the trial which is called expansion phase where a recommended dose of studied medicine obtained from previous part of the trial will be tested. The purpose of the dose expansion of the study is to determine the most effective and safe dose of SAR443216 for treatment of your disease, study side effects and whether the medicine can control or improve the disease.
The trial is looking to recruit patients ≥ 18 years eligible for this treatment across 5 NHS hospitals in the UK. Before start of the treatment patients will have physical examination, ECG, ECHO/MUGA, Head MRI, Chest X-ray, CT/PET CT scans, vital signs and other blood tests as per trial protocol. Expansion part: Cycle 1 Week 1, administration at D1 and D4, then weekly administration. After Cycle 1, weekly administration until the end of treatment. During the treatment for safety and to know how the treatment is working patients will have blood and urine samples taken and ECG done at various timepoints. Echo will be conducted at cycle 1, cycle 2 and thereafter every 3 cycles until end of trial. CT/MRI will be done every 8 weeks until end of trial. Patients will receive treatment until it stops working from them or they or their doctor decide to discontinue. They will be followed up for 5 months after the last dose.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0748
Date of REC Opinion
9 Jan 2024
REC opinion
Further Information Favourable Opinion