MEN1309-01, CD205-SHUTTLE, Solid Tumours and Non-Hodgkin Lymphoma
Research type
Research Study
Full title
Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate, in Patients with CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma
IRAS ID
226163
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
Menarini Ricerche S.p.A.
Eudract number
2017-001120-22
Duration of Study in the UK
3 years, 7 months, 1 days
Research summary
This is an Open-Label (all involved know which medication the participants are taking), Phase I (first in human), dose escalation study of MEN1309 (Study Drug) in Patients with CD205-Positive Metastatic Solid Tumours and Non-Hodgkin Lymphoma. Approximately 122 patients are expected to be enrolled across 8 sites in Europe, including 2 sites from the UK.
The main objective of the study is to identify the maximum tolerated dose (MTD) of MEN1309 when given as an IV infusion as well as identify the dose limiting toxicities (DLT - side effects that are serious enough to prevent an increase in dose or level of that treatment) of MEN1309. The study will be run in 2 sequential steps; Step 1 aims to establish the MTD and DLT in patients with CD205-positive advanced solid tumours and Step 2 aims to establish the DLT and MTD in patients with CD205-positive Non-Hodgkin Lymphoma.
All patients will undergo a maximum of a 12-week Pre Screening Period, followed by a 4-week Screening Period. Each treatment cycle will last approximately 3 weeks. The End of Study Visit will be performed 6 weeks after last administered dose. After the End of Study Visit, patients will be followed for survival status every 12 weeks up to a period of 12 months after first treatment administration to the last patient. Individual study duration will depend on the duration of treatment which continues up to disease progression for solid tumours and up to 8 cycles for NHL (further cycles beyond the 8th cycle may be allowed for patients who benefit from the treatment).
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0148
Date of REC Opinion
3 Jul 2017
REC opinion
Further Information Favourable Opinion