MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study

• Status: Terminated
• Trial end date: 2020-01-08
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group

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.