Phase I/IIa Study of DTP3 in Patients With Advanced MM and DLBCL

• Research type

  Research Study

• Full title

  Treating Multiple Myeloma and Diffuse Large B Cell Lymphoma by Targeting the NF-κB Pathway with the First-in-Class GADD45β/MKK7 Inhibitor, DTP3

• IRAS ID

  1004023

• Contact name

  Holger Auner

• Contact email

  holger.auner04@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Eudract number

  2021-004028-13

• Research summary

  The study is designed to assess the safety and effectiveness of a new molecule, DTP3, in the treatment of patients with relapsed/refractory Multiple Myeloma (MM) and Diffuse Large B Cell Lymphoma (DLBCL). Multiple Myeloma is a cancer of plasma cells, which has a current median survival of approximately 5 years. There is no cure for MM and the vast majority of patients eventually relapse or become resistant to therapy. The prognosis for patients with relapsed MM which is no longer responsive to standard treatment remains poor. DLBCL is a cancer of the B cells. Whilst the majority of patients with DLBCL can effectively be cured with immuno-chemotherapy treatment, over a third will either be refractory to therapy or relapse after an initial response. The prognosis in this population remains poor.

  In both MM and DLBCL, the NF-κB signalling pathway has been shown to be involved in cancer cell survival. NF-κB is involved in many normal cellular functions, which is why targeting this pathway has proved to be difficult and results in unintended toxicity. DTP3 has been shown in laboratory studies to target the NF-κB to cause cancer cell death, while not being toxic to normal cells. A previous proof of concept study in 3 patients with MM showed DTP3 has no serious adverse effects.
  In this study, patients will be treated with DTP3 three times per week (4 weeks is one cycle) until disease progression or unacceptable toxicity. The study has a dose escalation and dose expansion stage. Up to 24 patients with MM and DLBCL will be enrolled into the dose escalation phase. The escalation stage will determine the maximum tolerated dose (MTD). The MTD will be used in the expansion stage which will recruit 24 MM and 24 DLBCL patients each. The study is expected to last approximately 40 months and is being funded by the Medical Research Council

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  21/LO/0794

• Date of REC Opinion

  21 Dec 2021

• REC opinion

  Further Information Favourable Opinion