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Metastatic Solid TumorsPhase 1CD205SHUTTLENCT03403725

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

A Phase 1 study testing MEN1309 in people with Metastatic Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma, run by Menarini Group at 7 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgkin Lymphoma Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MEN1309
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
7 sitesin 4 countries
Study dates
28 Aug 2017to 8 Jan 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Male or female patients aged ≥ 18 years.
  2. Patients with:
  • confirmed diagnosis of advanced or metastatic solid tumor and diagnosis of multiple relapsed or refractory NHL;
  • progressive after last treatment received;
  • availability of archived tumor material, either as a block or slides;
  • measurable or evaluable disease by Response Evaluation Criteria in solid tumors guideline (RECIST v1.1) and by Cheson Criteria (The Lugano Classification, 2014) in NHL.
  1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
  2. Neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; haemoglobin ≥ 9 g/dL.
  3. Adequate renal and hepatic laboratory assessments.
  4. Life expectancy of at least 2 months.
  5. Woman of childbearing potential (WOCBP) who agrees to use highly effective contraception (see Appendix I).

Main Exclusion Criteria:

  1. Central nervous system involvement (excluding treated stable cerebral metastasis, not requiring therapy to control symptoms in the last 60 days).
  2. Pregnant or breastfeeding women.
  3. Life-threatening illnesses other than solid tumors and NHL, uncontrolled medical conditions or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety, or put the study outcomes at risk.
  4. Less than 2 previous cancer treatments, including high dose chemotherapy and ASCT, for NHL unless patient refuses standard therapy and/or is not eligible for ASCT.
  5. Have significant, uncontrolled, or active cardiovascular disease.

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Spain3 sites

  • Vall d'Hebron Barcelona Hospital

    Barcelona

  • START Madrid. Fundacion Jimenez Diaz

    Madrid, 28040

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

Other trials in Spain

Italy2 sites

  • Centro Riferimento Oncologico

    Aviano, 33081

  • IRCCS Ospedale San Raffaele

    Milan, 20132

Other trials in Italy

Belgium1 site

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

United Kingdom1 site

  • NCCC Clinical Trials Pharmacy, Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

About this study

Official title: Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate,in Patients With CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma

The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgkin Lymphoma

Read the detailed description

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

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

The clinical trial consists of two sequential parts:

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

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

Being tested
MEN1309
Keywords
Solid Tumors, Non-Hodgkin Lymphoma, NHL, MEN1309, CD205, Relapsed, Refractory, R-R NHL, ADC, Antibody-Drug Coniugate, Metastatic Tumors
Medical subject headings
Lymphoma, Non-Hodgkin, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEN1309Drug

    MEN1309 solution for intravenous infusion once every 3 weeks

Study groups in NCT03403725
Study groupRoleWhat they receive
MEN1309 (Step 1-Solid Tumors)/(Step 2-NHL)ExperimentalStep1: Accelerated Titration Design with 1 single pt per cohort and double dose level per cohort until grade ≥ 2 drug related toxicity. Then, study reverts to 3+3 design. Any cohort in which 1 pt experiences a DLT (along ATD or 3+3) will be expanded up to 6 pts. Step2: MTD defined in Step 1, 3 MEN1309 dose levels will be tested (MTD-2, MTD-1, and MTD), with 6 pts per each dose level. A further MTD-3 level will be explored if 2 DLTs occur at the MTD-2 dose level.
Receives: Drug: MEN1309

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum-Tolerated Dose (MTD)

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

    Measured: 21-day period after the first dose

  2. Dose-Limiting Toxicity (DLT)

    Adverse drug reactions (ADRs) that will be assessed during Cycle 1:

    • any grade ≥ 3 cardiac toxicity, new segmental wall-motion abnormalities, or cardiac troponin I or T elevation of grade 3 or higher;
    • any grade ≥ 3 elevations in total bilirubin, hepatic transaminases, or ALP levels; in patients with baseline grade 2 hepatic transaminase or ALP levels, an elevation to ≥ 10 x ULN is considered a DLT;
    • any grade 3 non-haematologic toxicity lasting > 7 days, (excluding diarrhea/nausea for which no adequate and optimal therapy has been implemented and alopecia);
    • any grade 3 vomiting lasting > 3 days despite adequate and optimal therapy;
    • any grade ≥ 4 non-haematologic toxicity;
    • any grade 4 thrombocytopenia or anemia;
    • any grade 4 neutropenia lasting > 7 days or febrile neutropenia;
    • any treatment delay of > 2 weeks because of delayed recovery from toxicity related to MEN1309 (except for alopecia).

    Measured: 21-day period after the first dose

Secondary outcomes (11)

  1. Overall Survival

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

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

  2. Progression Free Survival

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

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

  3. Preliminary Tumor Activity (RR)

    Preliminary tumor activity (RR) Response Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.

    Measured: From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)

  4. Preliminary Antitumor Activity (DCR)

    Preliminary Antitumor Activity (DCR) Disease control Rate. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.

    Measured: From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)

  5. Preliminary Antitumor Activity (DOR)

    Prliminary Antitumor Activity. Measure of the Duration of response. RECIST v 1.1 assessment was performed using CT or MRI scan of the chest and abdomen (including adrenal glands). For the baseline assessment, CT or MRI scan were to be performed no more than 6 weeks (4+2 weeks) before the treatment start. Follow-up assessment were performed every other cycle starting from cycle 3 until the End of Study Visit.

    Measured: From Day1Visit1 to End of the treatment (At Baseline no more than 6 weeks before treatment and then every cycle starting from cycle 3 until End of Study)

  6. MEN1309 PK Parameter Cmax

    Cmax is the maximum drug concentration

    Measured: Cycle 1

  7. MEN1309 PK Parameter Ctrough

    MEN1309 PK parameter Ctrough (Predose concentration)

    Measured: Pre-infusion Cycle 2

  8. MEN1309 Pharmacokinetic (PK) Parameter t1/2

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

    Measured: Cycle 1

  9. MEN1309 Pharmacokinetic (PK) Parameter AUC

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

    Measured: Cycle 1

  10. MEN1309 (PK) Parameter CL

    Systemic clearance of MEN1309 Pharmacokinetic

    Measured: Cycle 1

  11. MEN1309 Pharmacokinetic (PK) Parameter Vd

    volume of distribution based on the terminal phase

    Measured: Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2018
  2. Study start28 Aug 2017
  3. Primary completion22 Oct 2019
  4. Study completion8 Jan 2020

Why it stopped: Terminated after achievement of MTD, without progressing to cohort expansion for Company decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Cohort1 0.05mg/kg STEP 1 Solid Tumors Cohort2 0.10mg/kg STEP 1 Solid Tumors Cohort3 0.20mg/kg STEP 1 Solid Tumors Cohort4 0.40mg/kg STEP 1 Solid Tumors Cohort5 0.80mg/kg STEP 1 Solid Tumors Cohort6 1.60mg/kg STEP 1 Solid Tumors Cohort7 2.40mg/kg STEP 1 Solid Tumors Cohort8 3.36mg/kg STEP 1 Solid Tumors + GCSF Cohort7b 2.40mg/kg STEP 1 Solid Tumors +GCSF Cohort7c 2.00mg/kg STEP 1 Solid Tumors +GCSF Cohort5 0.80mg/kg STEP 2 NHL
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03403725
Sponsor's protocol ID
MEN1309-01
Acronym
CD205SHUTTLE
Status last verified
Feb 2021
First submitted
4 Jan 2018
Last updated
28 Sep 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEN1309 in people with Metastatic Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma, run by Menarini Group at 7 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, Italy, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum-Tolerated Dose (MTD) (time frame: 21-day period after the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.

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