Trial Outcomes & Findings for MEN1309 I.v. Infusion in Pts With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory NHL Ph I Study (NCT NCT03403725)

Last Updated: 2021-09-28

Results Overview

Defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT during the DLT assessment window.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

21-day period after the first dose

Results posted on

2021-09-28

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Overall Study STARTED	1	1	1	1	1	6	6	3	3	4	1
Overall Study COMPLETED	1	1	1	1	1	6	6	3	3	4	1
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort1 0.05mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved 0.05mg/kg of MEN1309.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved 0.10mg/kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved 0.20mg/kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved 0.40mg/kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved 0.80mg/kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved 1.60mg/kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved 3.36mg/kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved 2.40mg/kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved 2.00mg/kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	18 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	10 Participants n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	6 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	19 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	9 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	1 participants n=42 Participants	1 participants n=42 Participants	0 participants n=42 Participants	2 participants n=42 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	6 participants n=8 Participants	6 participants n=8 Participants	3 participants n=24 Participants	2 participants n=42 Participants	3 participants n=42 Participants	1 participants n=42 Participants	26 participants n=42 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Race/Ethnicity, Customized Black African American	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Race/Ethnicity, Customized White	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	6 participants n=8 Participants	6 participants n=8 Participants	3 participants n=24 Participants	3 participants n=42 Participants	4 participants n=42 Participants	1 participants n=42 Participants	28 participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	1 participants n=8 Participants	1 participants n=8 Participants	1 participants n=24 Participants	1 participants n=42 Participants	0 participants n=42 Participants	0 participants n=42 Participants	5 participants n=42 Participants
Region of Enrollment Italy	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	1 participants n=8 Participants	0 participants n=24 Participants	0 participants n=42 Participants	1 participants n=42 Participants	0 participants n=42 Participants	2 participants n=42 Participants
Region of Enrollment Spain	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	5 participants n=8 Participants	5 participants n=8 Participants	2 participants n=24 Participants	2 participants n=42 Participants	3 participants n=42 Participants	1 participants n=42 Participants	0 participants n=42 Participants
Weight	66.10 Kg STANDARD_DEVIATION 0 • n=5 Participants	56.80 Kg STANDARD_DEVIATION 0 • n=7 Participants	60.60 Kg STANDARD_DEVIATION 0 • n=5 Participants	62.50 Kg STANDARD_DEVIATION 0 • n=4 Participants	53.50 Kg STANDARD_DEVIATION 0 • n=21 Participants	64.27 Kg STANDARD_DEVIATION 17.382 • n=8 Participants	67.30 Kg STANDARD_DEVIATION 15.725 • n=8 Participants	61.17 Kg STANDARD_DEVIATION 8.520 • n=24 Participants	76.57 Kg STANDARD_DEVIATION 15.584 • n=42 Participants	64.55 Kg STANDARD_DEVIATION 8.805 • n=42 Participants	109.4 Kg STANDARD_DEVIATION 0 • n=42 Participants	66.68 Kg STANDARD_DEVIATION 12.886 • n=42 Participants

PRIMARY outcome

Timeframe: 21-day period after the first dose

Population: MTD was evaluated only in the STEP 1 since in STEP 2 only one patient was treated.

Defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT during the DLT assessment window.

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=27 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Maximum-Tolerated Dose (MTD)	1.6 mg/Kg	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 21-day period after the first dose

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).

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
Dose-Limiting Toxicity (DLT)	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	1 Dose Limiting Toxicities	1 Dose Limiting Toxicities	2 Dose Limiting Toxicities	3 Dose Limiting Toxicities	2 Dose Limiting Toxicities	0 Dose Limiting Toxicities

SECONDARY outcome

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

Population: For Cohorts reported as 0 analyzed the patients were censored (Event Date Not available)

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

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	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.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	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.	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.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	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.
Overall Survival	—	379 Days Standard Deviation 0	700 Days Standard Deviation 0	—	74 Days Standard Deviation 0	154 Days Standard Deviation 0	297.75 Days Standard Deviation 208.73	—	—	90.33 Days Standard Deviation 12.66	—

SECONDARY outcome

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

Population: For Cohorts reported as 0 analyzed the patients were censored (Event Date Not available)

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

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	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.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	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.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=2 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	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.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=2 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	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.
Progression Free Survival	—	—	41 Days Standard Deviation 0	—	38 Days Standard Deviation 0	36.5 Days Standard Deviation 0.71	155.5 Days Standard Deviation 190.51	—	100.5 Days Standard Deviation 28.99	37 Days Standard Deviation 1.73	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	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.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	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.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	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.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=2 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=4 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
Preliminary Tumor Activity (RR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	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.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	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.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	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.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=2 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=4 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
Preliminary Antitumor Activity (DCR)	0 N. of Stable Disease/N. of Pts	0 N. of Stable Disease/N. of Pts	0 N. of Stable Disease/N. of Pts	—	1 N. of Stable Disease/N. of Pts	—	0.33 N. of Stable Disease/N. of Pts	0.8 N. of Stable Disease/N. of Pts	—	0 N. of Stable Disease/N. of Pts	0.25 N. of Stable Disease/N. of Pts

SECONDARY outcome

Timeframe: 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)

Population: Data Cannot be reported since it was not analyzed. No Patients had Complete response and Partial Response.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1

Cmax is the maximum drug concentration

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
MEN1309 PK Parameter Cmax	0.73 microgram/mL Standard Deviation 0.19	0.87 microgram/mL Standard Deviation 0.16	1.75 microgram/mL Standard Deviation 0.09	3.16 microgram/mL Standard Deviation 0	9.67 microgram/mL Standard Deviation 2.03	31.87 microgram/mL Standard Deviation 9.11	43.94 microgram/mL Standard Deviation 11.25	64.97 microgram/mL Standard Deviation 33.40	44.50 microgram/mL Standard Deviation 15.79	33.52 microgram/mL Standard Deviation 9.29	11.36 microgram/mL Standard Deviation 0

SECONDARY outcome

Timeframe: Pre-infusion Cycle 2

Population: For Cohort 4 the treatment ended at Cycle 1 for the only subejct.

MEN1309 PK parameter Ctrough (Predose concentration)

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	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.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
MEN1309 PK Parameter Ctrough	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	—	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0	0 ng/mL Standard Deviation 0

SECONDARY outcome

Timeframe: Cycle 1

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

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
MEN1309 Pharmacokinetic (PK) Parameter t1/2	2.66 hr Standard Deviation 0	3.17 hr Standard Deviation 0	2.38 hr Standard Deviation 0	16.65 hr Standard Deviation 0	93.90 hr Standard Deviation 0	18.24 hr Standard Deviation 6.49	16.89 hr Standard Deviation 1.67	27.74 hr Standard Deviation 2.36	15.36 hr Standard Deviation 0.96	17.24 hr Standard Deviation 1.24	15.08 hr Standard Deviation 0

SECONDARY outcome

Timeframe: Cycle 1

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

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
MEN1309 Pharmacokinetic (PK) Parameter AUC	3.94 hr * microgram/mL Standard Deviation 0	3.78 hr * microgram/mL Standard Deviation 0	6.16 hr * microgram/mL Standard Deviation 0	11.86 hr * microgram/mL Standard Deviation 0	57.49 hr * microgram/mL Standard Deviation 0	583.38 hr * microgram/mL Standard Deviation 213.45	1038.12 hr * microgram/mL Standard Deviation 257.12	2045.41 hr * microgram/mL Standard Deviation 1130.69	958.94 hr * microgram/mL Standard Deviation 417.06	689.33 hr * microgram/mL Standard Deviation 295.50	111.44 hr * microgram/mL Standard Deviation 0

SECONDARY outcome

Timeframe: Cycle 1

Systemic clearance of MEN1309 Pharmacokinetic

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
MEN1309 (PK) Parameter CL	0.82 L/hr Standard Deviation 0	1.46 L/hr Standard Deviation 0	1.96 L/hr Standard Deviation 0	2.06 L/hr Standard Deviation 0	0.70 L/hr Standard Deviation 0	0.20 L/hr Standard Deviation 0.09	0.17 L/hr Standard Deviation 0.08	0.13 L/hr Standard Deviation 0.9	0.21 L/hr Standard Deviation 0.07	0.22 L/hr Standard Deviation 0.11	0.78 L/hr Standard Deviation 0

SECONDARY outcome

Timeframe: Cycle 1

volume of distribution based on the terminal phase

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=1 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.10 mg/Kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.20 mg/Kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.40 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 0.80 mg/Kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 1.60 mg/Kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 3.36 mg/Kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.40 mg/Kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 Participants Patients with CD205-positive advanced solid tumors, who recieved a dose of 2.00 mg/Kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 Participants Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved a dose of 0.80 mg/Kg of MEN1309.
MEN1309 Pharmacokinetic (PK) Parameter Vd	3.14 L Standard Deviation 0	6.69 L Standard Deviation 0	6.73 L Standard Deviation 0	49.47 L Standard Deviation 0	95.45 L Standard Deviation 0	4.97 L Standard Deviation 2.5	4.02 L Standard Deviation 1.32	4.73 L Standard Deviation 1.80	5.55 L Standard Deviation 3.24	5.08 L Standard Deviation 3.08	16.94 L Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

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

Population: N.B: No Data were available to assess this outcome.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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

Population: For this Outcome Results are not available per Cohorts, but only on the total of patients analyzed.

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

Outcome measures

Outcome measures
Measure	All Doses STEP 1-Solid Tumors n=28 Participants All Patients with CD205-positive advanced solid tumors inlcuded in STEP1.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.
Incidence of Anti-MEN1309 Antibodies ADA Positive	10 Patients	—	—	—	—	—	—	—	—	—	—
Incidence of Anti-MEN1309 Antibodies ADA Negative	18 Patients	—	—	—	—	—	—	—	—	—	—

Deaths: 3 deaths

Cohort5 0.80mg/kg STEP 2 NHL

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort1 0.05mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.05 mg/kg of MEN1309.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.10 mg/kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.20 mg/kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.40 mg/kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.80 mg/kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 1.60 mg/kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 3.36 mg/kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 2.00 mg/kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 participants at risk Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309.
Vascular disorders Embolism venous	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Investigations Neutrophil count decreased	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Investigations ECOG performance Status Worsened	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Respiratory, thoracic and mediastinal disorders Pulmunary Embolism	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	66.7% 2/3 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 3/3 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	50.0% 2/4 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Nervous system disorders Aphasia	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Nervous system disorders Hemiparesis	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Disease Progression	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Gastric Haemorrhage	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Renal and urinary disorders Renal failure	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Metabolism and nutrition disorders Decrease appetite	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Infections and infestations Device related infection	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	25.0% 1/4 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Infections and infestations Peritonitis	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Infections and infestations Sepsis	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)

Other adverse events

Other adverse events
Measure	Cohort1 0.05mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.05 mg/kg of MEN1309.	Cohort2 0.10mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.10 mg/kg of MEN1309.	Cohort3 0.20mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.20 mg/kg of MEN1309.	Cohort4 0.40mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.40 mg/kg of MEN1309.	Cohort5 0.80mg/kg STEP 1 Solid Tumors n=1 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 0.80 mg/kg of MEN1309.	Cohort6 1.60mg/kg STEP 1 Solid Tumors n=6 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 1.60 mg/kg of MEN1309.	Cohort7 2.40mg/kg STEP 1 Solid Tumors n=6 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.	Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF n=3 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 3.36 mg/kg of MEN1309.	Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF n=3 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 2.40 mg/kg of MEN1309.	Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF n=4 participants at risk Patients with CD205-advanced Solid Tumor, who recieved 2.00 mg/kg of MEN1309.	Cohort5 0.80mg/kg STEP 2 NHL n=1 participants at risk Patients with CD205-positive multiple relapsed or refractory Non Hodking Lymphoma, who recieved 0.80mg/kg of MEN1309.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Investigations Blood Bliriubin increased	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	25.0% 1/4 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Investigations lymphocyte count decresed	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Investigations Neutrophil count decreased	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	83.3% 5/6 • Number of events 9 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 6/6 • Number of events 12 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 4/4 • Number of events 7 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Investigations Platelet count decreased	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	66.7% 2/3 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	50.0% 2/4 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Investigations white blood cell count decreased	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	25.0% 1/4 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Respiratory, thoracic and mediastinal disorders Dysphonia	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Blood and lymphatic system disorders Dizziness	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Diorrhoea	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	50.0% 3/6 • Number of events 5 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Asthenia	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Chest Pain	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Fatigue	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	50.0% 3/6 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	50.0% 3/6 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	50.0% 2/4 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Oedema Pheripheral	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Pyrexia	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	25.0% 1/4 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Psychiatric disorders Depression	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	25.0% 1/4 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Adnominal disorders	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Constipation	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
General disorders Dyspepsia	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Gastrooesphageal reflux disease	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Nausea	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	66.7% 4/6 • Number of events 4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	50.0% 2/4 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Stomatitis	100.0% 1/1 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 3/3 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	66.7% 2/3 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Gastrointestinal disorders Vomiting	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 2/6 • Number of events 2 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	100.0% 1/1 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)
Infections and infestations Urinary tract infection	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/6 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	16.7% 1/6 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	33.3% 1/3 • Number of events 1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/3 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/4 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)	0.00% 0/1 • Through study completion, from "August 28, 2017" to "January 8, 2020" (2 years and 4 months)

Additional Information

Corporate Director of Clinical Sciences

Menarini Ricerche SPA

Phone: +39 055 56809933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60