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Phase I/IIa Study of DTP3 in Patients With Advanced Multiple Myeloma

  • Research type

    Research Study

  • Full title

    A Phase I/IIa Dose Escalation, And Subsequent Cohort Expansion Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Preliminary Clinical Efficacy Of Intravenous DTP3 In Patients With Relapsed Or Refractory Multiple Myeloma

  • IRAS ID

    184768

  • Contact name

    Jane Apperley

  • Contact email

    j.apperley@imperial.ac.uk

  • Sponsor organisation

    Imperial College London

  • Eudract number

    2015-003459-23

  • Duration of Study in the UK

    3 years, 3 months, 23 days

  • Research summary

    TITLE: To investigate the Safety and Preliminary Clinical Efficacy of DTP3 in patients with relapsed or refractory Multiple Myeloma

    The study is designed to assess the safety and effectiveness of a new molecule, DTP3, in the treatment of patients with Multiple Myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which has a current median survival of approximately 5 years. There is no cure for MM and the majority of patients eventually relapse or become resistant to therapy. As a result, there is an urgent need for new therapeutic approaches. The NF-kB signalling pathway is extensively implicated in the pathogenesis of MM, however strategies to target this protein complex have resulted in limited clinical effectiveness due to extensive toxicity. DTP3 overcomes this problem by targeting downstream effectors of NF-kB, resulting in inhibition of its function without being toxic to healthy cells. The resultant effect of DTP3 treatment in pre-clinical models is to shrink tumours by inducing cell death in MM cells while leaving healthy cells intact. Indeed it has also been shown to work in drug resistant MM cell lines. The study will be recruiting up to 58 patients with advanced Multiple Myeloma across five London hospitals. The design of the trial will be in two stages; Firstly, dose escalation where each patient will be treated 3 times per week to determine the maximum tolerated dose (MTD). Safety will be assessed after 4 weeks before escalating to the next dose level in a new patient group. Secondly, the expansion cohort stage will be initiated at either the maximum tolerated dose (MTD) or a clinically effective dose. Each patient will receive DTP3 3 times per week until disease progression or unacceptable toxicity for a period up to 16 weeks.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    15/LO/1908

  • Date of REC Opinion

    27 Nov 2015

  • REC opinion

    Favourable Opinion