TerminatedPhase 1

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

Stopped: Terminated after achievement of MTD, without progressing to cohort expansion for Company decision.

Belgium, Italy, Spain28 participantsStarted 2017-08-28

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female patients aged ≥ 18 years.
✓. Patients with:
✓. 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).

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.

What they're measuring

Maximum-Tolerated Dose (MTD)

Timeframe: 21-day period after the first dose

Dose-Limiting Toxicity (DLT)

Timeframe: 21-day period after the first dose

Trial details

NCT IDNCT03403725

SponsorMenarini Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-22

Results submitted2021-01-04

View on ClinicalTrials.gov More Metastatic Solid Tumors trials