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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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