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MEN1309 Intravenous Infusion in Patients With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory Non-Hodgkin Lymphoma Phase I Study (CD205-SHUTTLE)

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ClinicalTrials.gov Identifier: NCT03403725
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Menarini Group

Brief 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

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumors Relapsed/Refractory Non-Hodgkin Lymphoma Drug: MEN1309 Phase 1

Detailed Description:

This clinical trial will investigate the safety and activity of MEN1309 in patients with CD205-positive metastatic solid tumors and Non-Hodgkin Lymphoma who have tried other types of treatment for cancer without adequate response (or the cancer came back). CD205 is a protein present in certain types of cancer.

This is a Phase I study, which means that it is designed to look at several dose levels of a study drug in small groups of patients to find the dose that is well-tolerated and suitable to be administered in subsequent clinical trials in patients. The clinical trial is also looking at the effectiveness of the study drug. This is the first time the study drug will be given in humans.

The clinical trial consists of two sequential parts:

  • Part 1 involves patients with CD205-positive metastatic solid tumors and the main purpose of this part of the clinical trial is to determine the highest dose of the study drug that can be used safely in these type of cancers.
  • Part 2 involves patients with CD205-positive Non-Hodgkin Lymphoma and will test doses of MEN1309 which have demonstrated to be adequately tolerated in patients with solid tumors.

Patients participating to the clinical trial will take the study drug as intravenous infusion once every 3 weeks. The clinical trial includes four periods: a pre-screening period (to check if tumor is positive for CD205), a screening period (to check whether the participation to the clinical trial is right for patient), a treatment period (when patient receives the study drug), and a follow-up period (to check the health status of the patient after stopping study treatment).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate,in Patients With CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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.

Drug: MEN1309
MEN1309 solution for intravenous infusion once every 3 weeks




Primary Outcome Measures :
  1. Maximum-Tolerated Dose (MTD) [ Time Frame: 21-day period after the first dose ]
  2. Dose-Limiting Toxicity (DLT) [ Time Frame: 21-day period after the first dose ]

Secondary Outcome Measures :
  1. MEN1309 Pharmacokinetic (PK) parameter Cmax [ Time Frame: Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days) ]
    Cmax is the maximum serum drug concentration

  2. MEN1309 Pharmacokinetic (PK) parameter Cmax (tmax) [ Time Frame: Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days) ]
    time to achieve maximum serum drug concentration

  3. MEN1309 Pharmacokinetic (PK) parameter Ctrough [ Time Frame: Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days) ]
    pre-dose serum concentration

  4. MEN1309 Pharmacokinetic (PK) parameter t1/2 [ Time Frame: Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days) ]
    terminal serum half-life

  5. MEN1309 Pharmacokinetic (PK) parameter AUC [ Time Frame: Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days) ]
    area under curve

  6. MEN1309 Pharmacokinetic (PK) parameter CL [ Time Frame: Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days) ]
    systemic clearance

  7. MEN1309 Pharmacokinetic (PK) parameter Vd [ Time Frame: Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days) ]
    volume of distribution based on the terminal phase

  8. Incidence of anti-MEN1309 antibodies [ Time Frame: Day 1 of each Cycle (each cycle is 21 days) ]
  9. Overall Survival [ Time Frame: Through study completion, an average of 3 years ]
  10. Progression free survival [ Time Frame: Through study completion, an average of 3 years ]
  11. Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Through study completion, an average of 3 years ]
    Incidence, intensity, CTCAE version 4.03 grading, seriousness and treatment-causality of TEAEs

  12. Correlation of CD205 expression in tumors with clinical activity of MEN1309 assessed according to RECIST 1.1 or Cheson Criteria (2014) in terms of Response Rate, Disease control rate, duration of response, overall survival, and progression free survival [ Time Frame: Through study completion, an average of 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403725


Contacts
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Contact: Serena Buontempo Clinical Research Physician, MD +39 055 5680 ext 9990 sbuontempo@menarini-ricerche.it
Contact: Mariagiuseppa Matera Clinical Project Manager +39 055 5680 ext 9990 mmatera@menarini-ricerche.it

Locations
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Belgium
CHU Sart Tilman Recruiting
Liège, Belgium, 4000
Spain
Vall d'Hebron Barcelona Hospital Recruiting
Barcelona, Spain
START Madrid. Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
United Kingdom
NCCC Clinical Trials Pharmacy, Northern Centre for Cancer Care Active, not recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Menarini Group
Investigators
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Study Chair: Josep Tabernero Head, Medical Oncology Department, MD PhD Vall d'Hebron University Hospital Vall d' Hebron Institute of Oncology (VHIO) P. Vall d'Hebron 119-129 08035 Barcelona, Spain

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Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT03403725     History of Changes
Other Study ID Numbers: MEN1309-01
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Menarini Group:
Solid Tumors
Non-Hodgkin Lymphoma
NHL
MEN1309
CD205
Relapsed
Refractory
R-R NHL
ADC
Antibody-Drug Coniugate
Metastatic Tumors

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases