Phase I trial using S65487, a Bcl-2 inhibitor in AML, NHL or MM
Research type
Research Study
Full title
Phase I,open label, non-randomised, non-comparative, multi-center study, evaluating S65487, a Bcl-2 inhibitor intraveneously administered, in patients with Relapse or Refractory Acute Myeloid Leukaemia, Non-Hodgkin Lymphoma or Multiple Myeloma
IRAS ID
258163
Contact name
Tobias Menne
Contact email
Eudract number
2018-004170-97
Duration of Study in the UK
4 years, 1 months, 4 days
Research summary
Phase I trial in patients with Acute Myeloid Leukaemia (AML); Non Hodgkin Lymphoma (NHL) or Multiple Myeloma (MM). This is a Dose Escalation (increasing the dose) Dose Expansion (confirming the dose and checking its safety and potential efficacy) trial.
The drug is a Bcl-2 inhibitor called 65487. The Bcl-2 (anti-apoptotic) protein is present in normal healthy cells and helps regulate cell turnover by helping unhealthy cells to die.
In some cancers, Bcl-2 is overexpressed, so cancer cells remain alive and able to continue to divide and proliferate.
By inhibiting Bcl-2 this leads to cell death of the cancer cells. In this trial we are assessing the efficacy of a new Bcl-2 inhibitor on 3 haematological cancers.
The aim of this trial is to check the safety of 65487 and acceptability in patients with AML, NHL and MM and to confirm the best dose. There will also be an initial check of the effectiveness of this drug on the patients cancer.
Patients will be given weekly iv infusion of 65487 in dose groups of 3 to 9 patients. Cycles are 3 weekly and patients will also be checked for their tumour response to the drug. Once the recommended dose has been confirmed an expansion trial or around 20 patients will be carried out to further check the safety and potentially some effectiveness of the drug at this dose.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0306
Date of REC Opinion
13 Jun 2019
REC opinion
Further Information Favourable Opinion