Phase 1b/2, multicenter, single arm study of RBN-2397 with pembrolizumab in patients with SCCL
Research type
Research Study
Full title
A Phase 1b/2, multicenter, single arm study of RBN-2397 in combination with pembrolizumab in patients with Squamous Cell Carcinoma of the Lung (SCCL)
IRAS ID
1004081
Contact name
Yvonne Summers
Contact email
Sponsor organisation
Ribon Therapeutics, Inc
Eudract number
2021-003829-30
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to evaluate the combination of RBN-2397 and pembrolizumab in patients with non-small cell lung cancer (NSCLC) of squamous cell histology, i.e., squamous cell carcinoma of the lung (SCCL). Ribon Therapeutics, Inc. has developed RBN-2397 which inhibits an enzyme called PARP7. PARP7 is switched on by cancer stresses, such as toxins in cigarette smoke. Cancer cells use PARP7 to hide from the immune system by stopping the cell from sending a signal that tells the immune system to kill the cell. Pembrolizumab belongs to a class of medicines known as immunotherapy and it works by helping the immune system to fight the cancer. It is approved for lung cancer patients. This study consists of two parts. The first part of the study aims to determine the most appropriate dose of RBN-2397 in combination with the standard dose of pembrolizumab. The main purpose of the second part of the study is to assess the effectiveness of the combination of RBN-2397 and pembrolizumab. Approximately 50 participants with SCCL, older than 18, will be involved in both parts of the study which will be conducted at hospitals in the USA, UK and Spain. All participants in both groups are required to have had certain prior treatments (chemotherapy containing platinum, and an 'immune checkpoint blockade inhibitor (ICI)' and the latter must have been the most recent treatment with a confirmed response. It is thought that the combination of RBN-2397 and pembrolizumab has the potential to restore sensitivity to treatment in SCCL patients that have already been treated with a previous ICI and had a response. As there are few therapeutics options for SCCL beyond second line treatments, the aim of this study is to develop a new therapeutic approach to add to the anti-cancer effects of ICI treatment and to improve upon any potential resistance to treatment. It is hoped this will result in better treatment outcomes. The study will last until the last participant finishes treatment.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0287
Date of REC Opinion
7 Feb 2022
REC opinion
Further Information Favourable Opinion