MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study (CD205SHUTTLE)
Metastatic Solid Tumors, Relapsed/Refractory Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Metastatic Solid Tumors focused on measuring Solid Tumors, Non-Hodgkin Lymphoma, NHL, MEN1309, CD205, Relapsed, Refractory, R-R NHL, ADC, Antibody-Drug Coniugate, Metastatic Tumors
Eligibility Criteria
Main Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- CHU Sart Tilman
- Centro Riferimento Oncologico
- IRCCS Ospedale San Raffaele
- Vall d'Hebron Barcelona Hospital
- START Madrid. Fundacion Jimenez Diaz
- Centro Integral Oncologico Clara Campal
- NCCC Clinical Trials Pharmacy, Northern Centre for Cancer Care
Arms of the Study
Arm 1
Experimental
MEN1309 (Step 1-Solid Tumors)/(Step 2-NHL)
Step1: Accelerated Titration Design with 1 single pt per cohort and double dose level per cohort until grade ≥ 2 drug related toxicity. Then, study reverts to 3+3 design. Any cohort in which 1 pt experiences a DLT (along ATD or 3+3) will be expanded up to 6 pts. Step2: MTD defined in Step 1, 3 MEN1309 dose levels will be tested (MTD-2, MTD-1, and MTD), with 6 pts per each dose level. A further MTD-3 level will be explored if 2 DLTs occur at the MTD-2 dose level.