Status:
TERMINATED
MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study
Lead Sponsor:
Menarini Group
Conditions:
Metastatic Solid Tumors
Relapsed/Refractory Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgk...
Detailed Description
This clinical trial will investigate the safety and activity of MEN1309 in patients with CD205-positive metastatic solid tumors and Non-Hodgkin Lymphoma who have tried other types of treatment for can...
Eligibility Criteria
Inclusion
- Main
- Male or female patients aged ≥ 18 years.
- Patients with:
- confirmed diagnosis of advanced or metastatic solid tumor and diagnosis of multiple relapsed or refractory NHL;
- progressive after last treatment received;
- availability of archived tumor material, either as a block or slides;
- measurable or evaluable disease by Response Evaluation Criteria in solid tumors guideline (RECIST v1.1) and by Cheson Criteria (The Lugano Classification, 2014) in NHL.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
- Neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; haemoglobin ≥ 9 g/dL.
- Adequate renal and hepatic laboratory assessments.
- Life expectancy of at least 2 months.
- Woman of childbearing potential (WOCBP) who agrees to use highly effective contraception (see Appendix I).
- Main
Exclusion
- Central nervous system involvement (excluding treated stable cerebral metastasis, not requiring therapy to control symptoms in the last 60 days).
- Pregnant or breastfeeding women.
- Life-threatening illnesses other than solid tumors and NHL, uncontrolled medical conditions or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or put the study outcomes at risk.
- Less than 2 previous cancer treatments, including high dose chemotherapy and ASCT, for NHL unless patient refuses standard therapy and/or is not eligible for ASCT.
- Have significant, uncontrolled, or active cardiovascular disease.
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03403725
Start Date
August 28 2017
End Date
January 8 2020
Last Update
September 28 2021
Active Locations (7)
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1
CHU Sart Tilman
Liège, Belgium, 4000
2
Centro Riferimento Oncologico
Aviano, Italy, 33081
3
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
4
Vall d'Hebron Barcelona Hospital
Barcelona, Spain