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TerminatedNCT03403725CD205SHUTTLEUpdated Sep 28, 2021Results posted

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

A Phase 1 interventional study of MEN1309 in Metastatic Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma, sponsored by Menarini Group. Terminated at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Menarini Group · Phase 1, Interventional, and Treatment

Why this study was terminated
Terminated after achievement of MTD, without progressing to cohort expansion for Company decision.
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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).

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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

Interventions

  • DrugMEN1309

    MEN1309 solution for intravenous infusion once every 3 weeks

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 21-day period after the first dose

  2. 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).

    Time frame: 21-day period after the first dose

Secondary outcomes

  1. Overall Survival

    Timeframe between the first study drug administration and death from any cause.

    Time frame: Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)

  2. Progression Free Survival

    The Number of days between the first study administration to the date of first documented disease progression.

    Time frame: Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)

  3. 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.

    Time frame: 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)

  4. 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.

    Time frame: 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)

  5. 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.

    Time frame: 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)

  6. MEN1309 PK Parameter Cmax

    Cmax is the maximum drug concentration

    Time frame: Cycle 1

  7. MEN1309 PK Parameter Ctrough

    MEN1309 PK parameter Ctrough (Predose concentration)

    Time frame: Pre-infusion Cycle 2

  8. MEN1309 Pharmacokinetic (PK) Parameter t1/2

    MEN1309 Pharmacokinetic (PK) parameter t1/2 (terminal serum half-life)

    Time frame: Cycle 1

  9. MEN1309 Pharmacokinetic (PK) Parameter AUC

    MEN1309 Pharmacokinetic (PK) parameter AUC (area under curve)

    Time frame: Cycle 1

  10. MEN1309 (PK) Parameter CL

    Systemic clearance of MEN1309 Pharmacokinetic

    Time frame: Cycle 1

  11. MEN1309 Pharmacokinetic (PK) Parameter Vd

    volume of distribution based on the terminal phase

    Time frame: Cycle 1

Other outcomes

  1. 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.

    Time frame: Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)

  2. Incidence of Anti-MEN1309 Antibodies

    Exploratory Endpoint: Immunogenicity analysis regarding the Incidence of anti-MEN1309 antibodies.

    Time frame: Day 1 of each Cycle (each cycle is 21 days)

06

Results

Posted Sep 28, 2021

Participant flow

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.

Participant flow — Overall Study
MilestoneCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Started11111663341
Completed11111663341
Not completed00000000000

Outcome measures

PrimaryMaximum-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.

Time frame:
21-day period after the first dose
Reported as:
Number · mg/Kg
Maximum-Tolerated Dose (MTD)
mg/KgAll Doses STEP 1-Solid Tumors
Maximum-Tolerated Dose (MTD)1.6
PrimaryDose-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).

Time frame:
21-day period after the first dose
Reported as:
Number · Dose Limiting Toxicities
Dose-Limiting Toxicity (DLT)
Dose Limiting ToxicitiesCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Dose-Limiting Toxicity (DLT)00000112320
SecondaryOverall Survival

Timeframe between the first study drug administration and death from any cause.

Time frame:
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Reported as:
Mean · Days
Overall Survival
DaysCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Overall Survival—379 ± 0700 ± 0—74 ± 0154 ± 0297.75 ± 208.73——90.33 ± 12.66—
SecondaryProgression Free Survival

The Number of days between the first study administration to the date of first documented disease progression.

Time frame:
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Reported as:
Mean · Days
Progression Free Survival
DaysCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Progression Free Survival——41 ± 0—38 ± 036.5 ± 0.71155.5 ± 190.51—100.5 ± 28.9937 ± 1.73—
SecondaryPreliminary 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.

Time frame:
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)
Reported as:
Count of participants · Participants
Preliminary Tumor Activity (RR)
ParticipantsCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Preliminary Tumor Activity (RR)00000000000
SecondaryPreliminary 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.

Time frame:
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)
Reported as:
Number · N. of Stable Disease/N. of Pts
Preliminary Antitumor Activity (DCR)
N. of Stable Disease/N. of PtsCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Preliminary Antitumor Activity (DCR)000—1—0.330.8—00.25
SecondaryPreliminary 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.

Time frame:
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)

No measurements were reported for this outcome.

SecondaryMEN1309 PK Parameter Cmax

Cmax is the maximum drug concentration

Time frame:
Cycle 1
Reported as:
Mean · microgram/mL
MEN1309 PK Parameter Cmax
microgram/mLCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
MEN1309 PK Parameter Cmax0.73 ± 0.190.87 ± 0.161.75 ± 0.093.16 ± 09.67 ± 2.0331.87 ± 9.1143.94 ± 11.2564.97 ± 33.4044.50 ± 15.7933.52 ± 9.2911.36 ± 0
SecondaryMEN1309 PK Parameter Ctrough

MEN1309 PK parameter Ctrough (Predose concentration)

Time frame:
Pre-infusion Cycle 2
Reported as:
Mean · ng/mL
MEN1309 PK Parameter Ctrough
ng/mLCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
MEN1309 PK Parameter Ctrough0 ± 00 ± 00 ± 0—0 ± 00 ± 00 ± 00 ± 00 ± 00 ± 00 ± 0
SecondaryMEN1309 Pharmacokinetic (PK) Parameter t1/2

MEN1309 Pharmacokinetic (PK) parameter t1/2 (terminal serum half-life)

Time frame:
Cycle 1
Reported as:
Mean · hr
MEN1309 Pharmacokinetic (PK) Parameter t1/2
hrCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
MEN1309 Pharmacokinetic (PK) Parameter t1/22.66 ± 03.17 ± 02.38 ± 016.65 ± 093.90 ± 018.24 ± 6.4916.89 ± 1.6727.74 ± 2.3615.36 ± 0.9617.24 ± 1.2415.08 ± 0
SecondaryMEN1309 Pharmacokinetic (PK) Parameter AUC

MEN1309 Pharmacokinetic (PK) parameter AUC (area under curve)

Time frame:
Cycle 1
Reported as:
Mean · hr * microgram/mL
MEN1309 Pharmacokinetic (PK) Parameter AUC
hr * microgram/mLCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
MEN1309 Pharmacokinetic (PK) Parameter AUC3.94 ± 03.78 ± 06.16 ± 011.86 ± 057.49 ± 0583.38 ± 213.451038.12 ± 257.122045.41 ± 1130.69958.94 ± 417.06689.33 ± 295.50111.44 ± 0
SecondaryMEN1309 (PK) Parameter CL

Systemic clearance of MEN1309 Pharmacokinetic

Time frame:
Cycle 1
Reported as:
Mean · L/hr
MEN1309 (PK) Parameter CL
L/hrCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
MEN1309 (PK) Parameter CL0.82 ± 01.46 ± 01.96 ± 02.06 ± 00.70 ± 00.20 ± 0.090.17 ± 0.080.13 ± 0.90.21 ± 0.070.22 ± 0.110.78 ± 0
SecondaryMEN1309 Pharmacokinetic (PK) Parameter Vd

volume of distribution based on the terminal phase

Time frame:
Cycle 1
Reported as:
Mean · L
MEN1309 Pharmacokinetic (PK) Parameter Vd
LCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
MEN1309 Pharmacokinetic (PK) Parameter Vd3.14 ± 06.69 ± 06.73 ± 049.47 ± 095.45 ± 04.97 ± 2.54.02 ± 1.324.73 ± 1.805.55 ± 3.245.08 ± 3.0816.94 ± 0
Other pre-specifiedCorrelation 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.

Time frame:
Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)

No measurements were reported for this outcome.

Other pre-specifiedIncidence of Anti-MEN1309 Antibodies

Exploratory Endpoint: Immunogenicity analysis regarding the Incidence of anti-MEN1309 antibodies.

Time frame:
Day 1 of each Cycle (each cycle is 21 days)
Reported as:
Number · Patients
Incidence of Anti-MEN1309 Antibodies
PatientsSTEP1 Solid Tumor All Doses + STEP 2 NHL
ADA Positive10
ADA Negative18

Adverse events

Collected over Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort1 0.05mg/kg STEP 1 Solid Tumors0/1 (0%)0/1 (0%)1/1 (100%)
Cohort2 0.10mg/kg STEP 1 Solid Tumors1/1 (100%)1/1 (100%)0/1 (0%)
Cohort3 0.20mg/kg STEP 1 Solid Tumors1/1 (100%)0/1 (0%)1/1 (100%)
Cohort4 0.40mg/kg STEP 1 Solid Tumors1/1 (100%)1/1 (100%)1/1 (100%)
Cohort5 0.80mg/kg STEP 1 Solid Tumors1/1 (100%)0/1 (0%)1/1 (100%)
Cohort6 1.60mg/kg STEP 1 Solid Tumors1/6 (16.7%)5/6 (83.3%)6/6 (100%)
Cohort7 2.40mg/kg STEP 1 Solid Tumors5/6 (83.3%)5/6 (83.3%)6/6 (100%)
Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF1/3 (33.3%)3/3 (100%)3/3 (100%)
Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF0/3 (0%)3/3 (100%)3/3 (100%)
Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF3/4 (75%)2/4 (50%)4/4 (100%)
Cohort5 0.80mg/kg STEP 2 NHL0/1 (0%)1/1 (100%)1/1 (100%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Embolism venousVascular disorders0/11/10/10/10/10/60/60/30/30/40/1
ECOG performance Status WorsenedInvestigations0/10/10/11/10/10/60/60/30/30/40/1
Febrile NeutropeniaBlood and lymphatic system disorders0/10/10/10/10/12/62/62/33/32/40/1
Renal failureRenal and urinary disorders0/10/10/10/10/10/60/60/30/30/41/1
HemiparesisNervous system disorders0/10/10/10/10/10/60/61/30/30/40/1
Disease ProgressionGeneral disorders0/10/10/10/10/10/61/60/31/30/40/1
Device related infectionInfections and infestations0/10/10/10/10/10/60/60/30/31/40/1
Neutrophil count decreasedInvestigations0/10/10/10/10/11/61/60/30/30/40/1
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/10/10/10/10/10/61/60/30/30/40/1
Pulmunary EmbolismRespiratory, thoracic and mediastinal disorders0/10/10/10/10/11/60/60/30/30/40/1
Most frequent other events
Showing 10 of 27
Most frequent other events
EventCohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHL
Neutrophil count decreasedInvestigations0/10/10/10/10/15/66/61/31/34/41/1
Platelet count decreasedInvestigations0/10/10/10/10/10/62/61/32/32/41/1
DysphoniaRespiratory, thoracic and mediastinal disorders1/10/10/10/10/10/60/61/30/30/40/1
DizzinessBlood and lymphatic system disorders1/10/10/10/10/10/61/61/30/30/40/1
DiorrhoeaGeneral disorders1/10/10/10/10/13/61/61/31/30/40/1
Chest PainGeneral disorders0/10/10/10/11/11/60/60/30/30/40/1
FatigueGeneral disorders1/10/10/10/11/13/63/60/31/32/40/1
Oedema PheripheralGeneral disorders0/10/10/11/10/10/61/60/30/30/40/1
DepressionPsychiatric disorders0/10/10/10/11/10/61/60/30/31/40/1
Adnominal disordersGastrointestinal disorders0/10/10/10/11/10/61/60/30/30/40/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHLTotal
<=18 years000000000000
Between 18 and 65 years1111143222018
>=65 years0000023112110
Sex: Female, Male
Sex: Female, Male(Participants)Cohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHLTotal
Female1111036312019
Male000013002219
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Cohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHLTotal
Hispanic or Latino000000001102
Not Hispanic or Latino1111166323126
Asian000000000000
American Indian or Alaska Native000000000000
Black African American000000000000
White1111166334128
Native Hawaiian or Other Pacific Islander000000000000
Other000000000000
Region of Enrollment
Region of Enrollment(participants)Cohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHLTotal
Belgium000011111005
Italy000000100102
Spain111105522310
Weight
Weight(Kg)Cohort1 0.05mg/kg STEP 1 Solid TumorsCohort2 0.10mg/kg STEP 1 Solid TumorsCohort3 0.20mg/kg STEP 1 Solid TumorsCohort4 0.40mg/kg STEP 1 Solid TumorsCohort5 0.80mg/kg STEP 1 Solid TumorsCohort6 1.60mg/kg STEP 1 Solid TumorsCohort7 2.40mg/kg STEP 1 Solid TumorsCohort8 3.36mg/kg STEP 1 Solid Tumors + GCSFCohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSFCohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSFCohort5 0.80mg/kg STEP 2 NHLTotal
Mean66.10 ± 056.80 ± 060.60 ± 062.50 ± 053.50 ± 064.27 ± 17.38267.30 ± 15.72561.17 ± 8.52076.57 ± 15.58464.55 ± 8.805109.4 ± 066.68 ± 12.886
07

Study locations

7 sites
  • CHU Sart Tilman
    Liège, 4000, Belgium
  • Centro Riferimento Oncologico
    Aviano, 33081, Italy
  • IRCCS Ospedale San Raffaele
    Milano, 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
08

References and documents

Study documents

  • Study protocol · Aug 31, 2018
  • Statistical analysis plan · Jan 7, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03403725
Lead sponsor
Menarini Group
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Aug 28, 2017
Primary completion
Oct 22, 2019
Completion
Jan 8, 2020
Results posted
Sep 28, 2021
Last update
Sep 28, 2021

Study contacts

Josep Tabernero Head, Medical Oncology Department, MD PhD
study chair · Vall d' Hebron Institute of Oncology (VHIO) P. Vall d'Hebron 119-129 08035 Barcelona, Spain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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