MEN1309 I.v. Infusion in Pts With CD205-positive Metastat... | NCT03403725 | Trialant
NCT03403725
Sponsor
Menarini Group
Status
Terminated
Last Update Posted
Sep 28, 2021Actual
Enrollment
28Actual
Phase
Phase 1
Conditions
Metastatic Solid Tumors
Relapsed/Refractory Non-Hodgkin Lymphoma
Interventions
MEN1309
Countries
Belgium
Italy
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03403725
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MEN1309-01
Secondary IDs
Not provided
Brief Title
MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study
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
Acronym
CD205SHUTTLE
Organization
Menarini GroupINDUSTRY
Status Module
Record Verification Date
Feb 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Terminated after achievement of MTD, without progressing to cohort expansion for Company decision.
Expanded Access Info
No
Start Date
Aug 28, 2017Actual
Primary Completion Date
Oct 22, 2019Actual
Completion Date
Jan 8, 2020Actual
First Submitted Date
Jan 4, 2018
First Submission Date that Met QC Criteria
Jan 10, 2018
First Posted Date
Jan 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jan 4, 2021
Results First Submitted that Met QC Criteria
Aug 31, 2021
Results First Posted Date
Sep 28, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 31, 2021
Last Update Posted Date
Sep 28, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Menarini GroupINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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
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).
Conditions Module
Conditions
Metastatic Solid Tumors
Relapsed/Refractory Non-Hodgkin Lymphoma
Keywords
Solid Tumors
Non-Hodgkin Lymphoma
NHL
MEN1309
CD205
Relapsed
Refractory
R-R NHL
ADC
Antibody-Drug Coniugate
Metastatic Tumors
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
28Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEN1309 (Step 1-Solid Tumors)/(Step 2-NHL)
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEN1309
Drug
MEN1309 solution for intravenous infusion once every 3 weeks
MEN1309 (Step 1-Solid Tumors)/(Step 2-NHL)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum-Tolerated Dose (MTD)
Defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT during the DLT assessment window.
21-day period after the first dose
Dose-Limiting Toxicity (DLT)
Adverse drug reactions (ADRs) that will be assessed during Cycle 1:
any grade ≥ 3 cardiac toxicity, new segmental wall-motion abnormalities, or cardiac troponin I or T elevation of grade 3 or higher;
any grade ≥ 3 elevations in total bilirubin, hepatic transaminases, or ALP levels; in patients with baseline grade 2 hepatic transaminase or ALP levels, an elevation to ≥ 10 x ULN is considered a DLT;
any grade 3 non-haematologic toxicity lasting > 7 days, (excluding diarrhea/nausea for which no adequate and optimal therapy has been implemented and alopecia);
any grade 3 vomiting lasting > 3 days despite adequate and optimal therapy;
any grade ≥ 4 non-haematologic toxicity;
any grade 4 thrombocytopenia or anemia;
any grade 4 neutropenia lasting > 7 days or febrile neutropenia;
any treatment delay of > 2 weeks because of delayed recovery from toxicity related to MEN1309 (except for alopecia).
21-day period after the first dose
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival
Timeframe between the first study drug administration and death from any cause.
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Progression Free Survival
Other Outcomes
Measure
Description
Time Frame
Correlation of CD205 Expression in Tumors With Clinical Activity of MEN1309 Assessed According to RECIST 1.1 or Cheson Criteria (2014)
Exploratory Endpoint: 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.
N.B: No Data were available to assess this outcome.
Eligibility Module
Eligibility Criteria
Main Inclusion Criteria:
Male or female patients aged ≥ 18 years.
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.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
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).
Main 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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Josep Tabernero Head, Medical Oncology Department, MD PhD
Vall d' Hebron Institute of Oncology (VHIO) P. Vall d'Hebron 119-129 08035 Barcelona, Spain
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
CHU Sart Tilman
Liège
4000
Belgium
Centro Riferimento Oncologico
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Male or female patients aged ≥ 18 years. For Step 1 of the study, patients with diagnosis of advanced or metastatic solid tumor. For Step 2, patients with histologically confirmed diagnosis of relapsed or refractory NHL. In both Steps the tumor need to have a positivity (≥ 1+ IHC staining) for CD205.
Recruitment Details
It was planned to perform this study in 7 sites across 4 European countries: Spain, Italy, Belgium, and UK. Patients were only recruited in 5 sites (3 ES, 1 IT1, 1 BE) prior to the study being stopped. The study started in date 28 August 2017 (FPI) to 19 November 2019 (LPLV). Study Termination letter was sent to authorities on 08 January 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
The Number of days between the first study administration to the date of first documented disease progression.
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Preliminary Tumor Activity (RR)
Preliminary tumor activity (RR) Response Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)
Preliminary Antitumor Activity (DCR)
Preliminary Antitumor Activity (DCR) Disease control Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)
Preliminary Antitumor Activity (DOR)
Prliminary Antitumor Activity. Measure of the Duration of response. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)
MEN1309 Pharmacokinetic (PK) parameter AUC (area under curve)
Cycle 1
MEN1309 (PK) Parameter CL
Systemic clearance of MEN1309 Pharmacokinetic
Cycle 1
MEN1309 Pharmacokinetic (PK) Parameter Vd
volume of distribution based on the terminal phase
Cycle 1
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Incidence of Anti-MEN1309 Antibodies
Exploratory Endpoint: Immunogenicity analysis regarding the Incidence of anti-MEN1309 antibodies.
Day 1 of each Cycle (each cycle is 21 days)
Aviano
33081
Italy
IRCCS Ospedale San Raffaele
Milan
20132
Italy
Vall d'Hebron Barcelona Hospital
Barcelona
Spain
START Madrid. Fundacion Jimenez Diaz
Madrid
28040
Spain
Centro Integral Oncologico Clara Campal
Madrid
28050
Spain
NCCC Clinical Trials Pharmacy, Northern Centre for Cancer Care
Newcastle upon Tyne
NE7 7DN
United Kingdom
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
FG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
FG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
FG004
Cohort5 0.80mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.
FG005
Cohort6 1.60mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.
FG006
Cohort7 2.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.
FG007
Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF
Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.
FG008
Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF
Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.
FG009
Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF
Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.
FG010
Cohort5 0.80mg/kg STEP 2 NHL
Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0056 subjects
FG0066 subjects
FG0073 subjects
FG0083 subjects
FG0094 subjects
FG0101 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0056 subjects
FG0066 subjects
FG0073 subjects
FG0083 subjects
FG0094 subjects
FG0101 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved 0.05mg/kg of MEN1309.
BG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved 0.10mg/kg of MEN1309.
BG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved 0.20mg/kg of MEN1309.
BG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved 0.40mg/kg of MEN1309.
BG004
Cohort5 0.80mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved 0.80mg/kg of MEN1309.
BG005
Cohort6 1.60mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved 1.60mg/kg of MEN1309.
BG006
Cohort7 2.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309.
BG007
Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF
Patients with CD205-positive advanced solid tumors, who recieved 3.36mg/kg of MEN1309.
BG008
Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF
Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309.
BG009
Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF
Patients with CD205-positive advanced solid tumors, who recieved 2.00mg/kg of MEN1309.
BG010
Cohort5 0.80mg/kg STEP 2 NHL
Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0021
BG0031
BG0041
BG0056
BG0066
BG0073
BG0083
BG0094
BG0101
BG01128
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Belgium
Title
Measurements
BG0000
BG0010
BG002
Weight
Mean
Standard Deviation
Kg
Title
Denominators
Categories
Title
Measurements
BG00066.10± 0
BG00156.80± 0
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum-Tolerated Dose (MTD)
Defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT during the DLT assessment window.
MTD was evaluated only in the STEP 1 since in STEP 2 only one patient was treated.
Posted
Number
mg/Kg
21-day period after the first dose
ID
Title
Description
OG000
All Doses STEP 1-Solid Tumors
All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.
Units
Counts
Participants
OG00027
Title
Denominators
Categories
Title
Measurements
OG0001.6
Primary
Dose-Limiting Toxicity (DLT)
Adverse drug reactions (ADRs) that will be assessed during Cycle 1:
any grade ≥ 3 cardiac toxicity, new segmental wall-motion abnormalities, or cardiac troponin I or T elevation of grade 3 or higher;
any grade ≥ 3 elevations in total bilirubin, hepatic transaminases, or ALP levels; in patients with baseline grade 2 hepatic transaminase or ALP levels, an elevation to ≥ 10 x ULN is considered a DLT;
any grade 3 non-haematologic toxicity lasting > 7 days, (excluding diarrhea/nausea for which no adequate and optimal therapy has been implemented and alopecia);
any grade 3 vomiting lasting > 3 days despite adequate and optimal therapy;
any grade ≥ 4 non-haematologic toxicity;
any grade 4 thrombocytopenia or anemia;
any grade 4 neutropenia lasting > 7 days or febrile neutropenia;
any treatment delay of > 2 weeks because of delayed recovery from toxicity related to MEN1309 (except for alopecia).
Posted
Number
Dose Limiting Toxicities
21-day period after the first dose
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Secondary
Overall Survival
Timeframe between the first study drug administration and death from any cause.
For Cohorts reported as 0 analyzed the patients were censored (Event Date Not available)
Posted
Mean
Standard Deviation
Days
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
OG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
Secondary
Progression Free Survival
The Number of days between the first study administration to the date of first documented disease progression.
For Cohorts reported as 0 analyzed the patients were censored (Event Date Not available)
Posted
Mean
Standard Deviation
Days
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
OG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
Secondary
Preliminary Tumor Activity (RR)
Preliminary tumor activity (RR) Response Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
Efficacy Population:All eligible patients who receive at least 2 complete treatment cycles and have at least 1 disease assessment are to be considered evaluable for efficacy.
The percentage of patient is 0% since no patient had Complete response or partial response.
Posted
Count of Participants
Participants
From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Secondary
Preliminary Antitumor Activity (DCR)
Preliminary Antitumor Activity (DCR) Disease control Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
Efficacy Population:All eligible patients who receive at least 2 complete treatment cycles and have at least 1 disease assessment are to be considered evaluable for efficacy.
Out of 11 evaluable patients, 11 patients had stable disease (SD), no complete response or partial response was observed.
Posted
Number
N. of Stable Disease/N. of Pts
From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Secondary
Preliminary Antitumor Activity (DOR)
Prliminary Antitumor Activity. Measure of the Duration of response. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.
Data Cannot be reported since it was not analyzed. No Patients had Complete response and Partial Response.
Posted
From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
Secondary
MEN1309 PK Parameter Cmax
Cmax is the maximum drug concentration
Posted
Mean
Standard Deviation
microgram/mL
Cycle 1
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
OG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
OG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
OG004
Cohort5 0.80mg/kg STEP 1 Solid Tumors
Secondary
MEN1309 Pharmacokinetic (PK) Parameter AUC
MEN1309 Pharmacokinetic (PK) parameter AUC (area under curve)
Posted
Mean
Standard Deviation
hr * microgram/mL
Cycle 1
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
OG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
OG004
Cohort5 0.80mg/kg STEP 1 Solid Tumors
Secondary
MEN1309 (PK) Parameter CL
Systemic clearance of MEN1309 Pharmacokinetic
Posted
Mean
Standard Deviation
L/hr
Cycle 1
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
OG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
OG004
Cohort5 0.80mg/kg STEP 1 Solid Tumors
Secondary
MEN1309 Pharmacokinetic (PK) Parameter Vd
volume of distribution based on the terminal phase
Posted
Mean
Standard Deviation
L
Cycle 1
ID
Title
Description
OG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.05 mg/Kg of MEN1309.
OG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.
OG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.
OG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.
OG004
Cohort5 0.80mg/kg STEP 1 Solid Tumors
Other Pre-specified
Correlation of CD205 Expression in Tumors With Clinical Activity of MEN1309 Assessed According to RECIST 1.1 or Cheson Criteria (2014)
Exploratory Endpoint: 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.
N.B: No Data were available to assess this outcome.
N.B: No Data were available to assess this outcome.
Posted
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
ID
Title
Description
OG000
STEP1 Solid Tumor All Doses + STEP 2 NHL
All Patients with CD205-positive advanced solid tumors inlcuded in STEP1 and all NHL patients included in STEP 2.
Units
Counts
Participants
OG000
Other Pre-specified
Incidence of Anti-MEN1309 Antibodies
Exploratory Endpoint: Immunogenicity analysis regarding the Incidence of anti-MEN1309 antibodies.
For this Outcome Results are not available per Cohorts, but only on the total of patients analyzed.
Posted
Number
Patients
Day 1 of each Cycle (each cycle is 21 days)
ID
Title
Description
OG000
STEP1 Solid Tumor All Doses + STEP 2 NHL
All Patients with CD205-positive advanced solid tumors inlcuded in STEP1 and all NHL patients included in STEP 2.
Units
Counts
Participants
OG00028
Time Frame
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort1 0.05mg/kg STEP 1 Solid Tumors
Patients with CD205-advanced Solid Tumor, who recieved 0.05 mg/kg of MEN1309.
0
1
0
1
1
1
EG001
Cohort2 0.10mg/kg STEP 1 Solid Tumors
Patients with CD205-advanced Solid Tumor, who recieved 0.10 mg/kg of MEN1309.
1
1
1
1
0
1
EG002
Cohort3 0.20mg/kg STEP 1 Solid Tumors
Patients with CD205-advanced Solid Tumor, who recieved 0.20 mg/kg of MEN1309.
1
1
0
1
1
1
EG003
Cohort4 0.40mg/kg STEP 1 Solid Tumors
Patients with CD205-advanced Solid Tumor, who recieved 0.40 mg/kg of MEN1309.
1
1
1
1
1
1
EG004
Cohort5 0.80mg/kg STEP 1 Solid Tumors
Patients with CD205-advanced Solid Tumor, who recieved 0.80 mg/kg of MEN1309.
1
1
0
1
1
1
EG005
Cohort6 1.60mg/kg STEP 1 Solid Tumors
Patients with CD205-advanced Solid Tumor, who recieved 1.60 mg/kg of MEN1309.
1
6
5
6
6
6
EG006
Cohort7 2.40mg/kg STEP 1 Solid Tumors
Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.
5
6
5
6
6
6
EG007
Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF
Patients with CD205-advanced Solid Tumor, who recieved 3.36 mg/kg of MEN1309.
1
3
3
3
3
3
EG008
Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF
Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.
0
3
3
3
3
3
EG009
Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF
Patients with CD205-advanced Solid Tumor, who recieved 2.00 mg/kg of MEN1309.
3
4
2
4
4
4
EG010
Cohort5 0.80mg/kg STEP 2 NHL
Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309.
0
1
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Embolism venous
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected4 at risk
EG0100 events0 affected1 at risk
Neutrophil count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
ECOG performance Status Worsened
Investigations
MedDRA (19.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected1 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)