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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Solid Tumors Relapsed/Refractory Non-Hodgkin Lymphoma||Drug: MEN1309||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
MEN1309 solution for intravenous infusion once every 3 weeks
- Maximum-Tolerated Dose (MTD) [ Time Frame: 21-day period after the first dose ]
- Dose-Limiting Toxicity (DLT) [ Time Frame: 21-day period after the first dose ]
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Incidence of anti-MEN1309 antibodies [ Time Frame: Day 1 of each Cycle (each cycle is 21 days) ]
- Overall Survival [ Time Frame: Through study completion, an average of 3 years ]
- Progression free survival [ Time Frame: Through study completion, an average of 3 years ]
- 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
- 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 ]
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
|Contact: Serena Buontempo Clinical Research Physician, MD||+39 055 5680 ext firstname.lastname@example.org|
|Contact: Mariagiuseppa Matera Clinical Project Manager||+39 055 5680 ext email@example.com|
|CHU Sart Tilman||Recruiting|
|Liège, Belgium, 4000|
|Vall d'Hebron Barcelona Hospital||Recruiting|
|START Madrid. Fundacion Jimenez Diaz||Recruiting|
|Madrid, Spain, 28040|
|Centro Integral Oncologico Clara Campal||Recruiting|
|Madrid, Spain, 28050|
|NCCC Clinical Trials Pharmacy, Northern Centre for Cancer Care||Active, not recruiting|
|Newcastle upon Tyne, United Kingdom, NE7 7DN|
|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|