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
Phase: PHASE1
Conditions: Metastatic Solid Tumors, Relapsed/Refractory Non-Hodgkin Lymphoma
Sponsor: Menarini Group

MEN1309-01-SHUTTLE205 STUDY
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 
 STUDY PROTOCOL 
NCT NUMBER: 
NCT03403725 
31.08.2018 

MENARINI 
RICERCHE 
CLINICAL TRIAL PROTOCOL 
FINAL VERSION 3.0, 31 AUG 2018 
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 
CD205 
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SOLDANO IWMATQOGIC UNIOUE TIMOR TARGET lfADINGTO EfF1CACY 
Study code: 
MEN1309-01 
Study Nick Name/ Acronym: 
CD205-SHUTTLE 
EudraCT-Number: 
2017-001120-22 
Investigational Medicinal Product: 
MEN1309 solution for intravenous infusion 
Development phase of study: 
Phase I 
SPONSOR 
Menarini Ricerche S.p.A. 
Clinical Sciences 
CO-ORDINATING INVESTIGATOR 
CRO 
STATEMENT OF CONFIDENTIALITY 
The infonnation in this document contains trade secrets and proprietaiy commerciai infonnation of Menarini Group 
that is privileged or confidential and may not be disclosed unless such disclosure is required by law. In any case, 
persons to whom the infonnation is disclosed must be infonned that the infonnation is privileged or confidential and 
may not be fwiher disclosed without written authorization by Menarini Group.