Study of HRO761 alone or in combination in cancer patients with DNA alterations called MSI or MMRD
Research type
Research Study
Full title
Study of HRO761 alone or in combination in cancer patients with specific DNA alterations called Microsatellite Instability - High or Mismatch Repair Deficiency.
IRAS ID
1007426
Contact name
Sofia Bisso
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
The main purpose of the study is to find the safe dose of HRO761 alone or in combination with tislelizumab or irinotecan, also called study treatments. HRO761 acts on a protein called Werner (WRN), which may contribute to cancer growth. By acting on WRN, HRO761 may be able to stop the growth of the cancers with defects called MSIhi (Microsatellite Instability-high) or dMMR (Mismatch Repair Deficient). This trial is designed to learn about the safety of the HRO761, and when combined with tislelizumab or irinotecan. This trial will find out how the body processes the study treatments, how the study treatments interact with the body as well as find out how well HRO761 alone or in combination with tislelizumab or irinotecan can treat those cancers.
The patient, the trial doctor, and Novartis will know the study treatment which is being given to each patient. There are two parts in this study. During part one, different groups of patients will be given different doses of HRO761 alone or in combination with either tislelizumab or irinotecan until the safe dose is found. In part two, more patients will be treated with the safe dose of HRO761 alone or in combination with either tislelizumab or irinotecan to further assess the study treatment effects against various types of MSIhi or dMMR cancers. Trial participation will last until the patient’s disease worsens, their doctor decides they should no longer participate in the trial, or the patient does not want to further participate in the trial.
Trial population:
(1) Adult patients with cancers that have defects called MSIhi or dMMR. Patients must have previously received other treatments but are no longer benefiting from them. (2) The cancer must be measurable. (3) Patients must be willing to have a biopsy of the cancer before receiving and during trial treatment. (4) Patients must not have significant heart disease, (5) must not have significant eye disorders, (6) must not have an active, serious infection.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0122
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Favourable Opinion