An investigational study using novel drug TH1902 in patients with advanced solid tumors.
Research type
Research Study
Full title
A Phase 1, Open-Label, Dose Escalation and Expansion Study of TH1902 in Patients with Advanced Solid Tumors
IRAS ID
1005740
Contact name
Christian Marsolais
Contact email
Sponsor organisation
Theratechnologies Inc.
Eudract number
2021-006500-32
Clinicaltrials.gov Identifier
Research summary
The purpose of this open-label multicentre clinical trial is to evaluate the investigational drug TH1902, a type of drug called a peptide drug conjugate. TH1902 works by targeting a receptor present on cancer cells called sortilin and using this receptor to enter the cancer cell where it then intereferes with cancer cell growth. Standard chemotherapy drugs, like docetaxel, lack specificity in the body and can attack both healthy and cancer cells. With this new TH1902 drug, docetaxel is attached to a small piece of protein (called a peptide) and carried into cancer cells that have a certain protein on their surface (called the sortilin receptor).
This clinical trial involves two parts:
Part I is a “dose escalation” phase where small groups of patients received increasing doses of TH1902 to find the safest dose which best targets cancer cells. Part II is a “dose expansion” phase where larger groups of patients with specific tumour types known to have high levels of the receptor sortilin, will receive the dose of TH1902 considered to be safe in Part I (identified as 300 mg/m2).
The main objectives of the clinical trial are to:
• Characterize the safety and tolerability of IV administered TH1902 (Parts 1 and 2).
• Identify the highest dose of TH1902 that can be given safely to patients (Part 1) and the optimum dose of TH1902 that can be used in future studies of TH1902 (Parts 1 and 2).
• Assess early signs of anti-cancer activity of TH1902 (Parts 1 and 2).
• See what happens to TH1902 inside the body following administration (Parts 1 and 2).
Part I of the trial took place in the United States (US) only. Part II of the study is expected to run in the US, Canada, Europe and the UK. It is estimated that approximately 85 to 100 patients will participate in this study (Part I & Part II). The trial will initially be conducted at one site in the UK. The clinical trial is sponsored by Theratechnologies Inc.REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0774
Date of REC Opinion
2 Feb 2023
REC opinion
Further Information Unfavourable Opinion