MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study
Condition: Metastatic Solid Tumors; Relapsed/Refractory Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: MEN1309
Intervention description: MEN1309 solution for intravenous infusion once every 3 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: Cohort1 0.05mg/kg STEP 1 Solid Tumors Cohort2 0.10mg/kg STEP 1 Solid Tumors Cohort3 0.20mg/kg STEP 1 Solid Tumors Cohort4 0.40mg/kg STEP 1 Solid Tumors Cohort5 0.80mg/kg STEP 1 Solid Tumors Cohort6 1.60mg/kg STEP 1 Solid Tumors Cohort7 2.40mg/kg STEP 1 Solid Tumors Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF Cohort5 0.80mg/kg STEP 2 NHL
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid Tumors; Non-Hodgkin Lymphoma; NHL; MEN1309; CD205; Relapsed; Refractory; R-R NHL; ADC; Antibody-Drug Coniugate; Metastatic Tumors

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-Hodgkin Lymphoma
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Male or female patients aged ≥ 18 years.

          2. 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.

          3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.

          4. Neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; haemoglobin ≥ 9 g/dL.

          5. Adequate renal and hepatic laboratory assessments.

          6. Life expectancy of at least 2 months.

          7. Woman of childbearing potential (WOCBP) who agrees to use highly effective
             contraception (see Appendix I).

        Main Exclusion Criteria:

          1. Central nervous system involvement (excluding treated stable cerebral metastasis, not
             requiring therapy to control symptoms in the last 60 days).

          2. Pregnant or breastfeeding women.

          3. 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.

          4. 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.

          5. Have significant, uncontrolled, or active cardiovascular disease.