Phase 1/2 study to investigate CRB-701 in Patients with Advanced solid tumours
Research type
Research Study
Full title
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients with Advanced Solid Tumours
IRAS ID
1009403
Contact name
Ian Hodgson
Contact email
Sponsor organisation
Corbus Pharmaceutical Inc.
Research summary
This is a 4 part open label, phase 1/2 clinical trial designed to to evaluate the safety, pharmacokinetics and efficacy of the drug, CRB-801, in participants with advanced solid tumours expressing nectin-4. The study is being done to find out if the CRB-701 can help people with advanced solid tumours. Also want to find out if the drug is safe to take without causing too many side effects.
There are 4 parts to the study. They are as follows:Part A
This part of the study will determine a high dose and a low dose of CRB-701 which will be utilised in Parts B and D of the study. The high and low dose will be decided by a Safety Review Committee (SRC) after review of safety data from Part A. They will recommend 2 doses to be taken forward to Part B.Part B
Part B of the study utilises a randomisation method to assign participants to a high dose or low dose of CRB-701.Part C
The participant in the study will be dose with the recommended phase 2 dose (RP2D) of the CRB-701. The RP2D will be decided by the Safety Review Committee (SRC) after review of safety data from Part A and Part B.Part D
The aim of Part D is to determine the recommended phase 2 dose (RP2D) of CRB-701 in combination with an approved of standardised dose regimen of anti-PD (L) 1 therapy.REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0076
Date of REC Opinion
21 Mar 2024
REC opinion
Further Information Favourable Opinion