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Breast CancerPhase 1SPAGOPIX-01NCT04080024

A First-in-human Clinical Evaluation of SN132D in Patients With Breast and Pancreatic Cancer

A Phase 1 study testing SN132D in people with Breast Cancer and Pancreas Cancer, run by Spago Nanomedical AB at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I, first-in-human (FIH) study is open-label, non-randomised and non-placebo-controlled. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single intravenous dose of SN132D in approximately 24 patients with breast and pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Pancreas Cancer
What is being tested?
SN132D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesSweden
Study dates
23 Aug 2019to 30 Nov 2022
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • Signed informed consent including willingness to undertake 3 MRI investigations (30 minute each) in one day
  • Histological or cytological diagnosis of breast cancer > 5 mm (cT1c-cT4; cN0-cN3; Mx) or known or suspected pancreatic cancer with hepatic involvement with available or scheduled gadolinium enhanced MRI of the pancreas
  • At least 3 weeks between core needle biopsy and planned pre-dose MRI. Fine needle aspiration is allowed at any time before MRI.
  • Female and at least 18 years of age when signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 at screening
  • Adequate renal and hepatic function: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 (determined by the revised Lund-Malmö GFR estimating equation), bilirubin <1 x upper limit of normal (ULN; (in subjects with liver metastases <5 x ULN)), creatinine <1 x ULN, aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 1 x ULN.
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  • Bilirubin ULN: 25 µmol/L, creatinine ULN: 90 µmol/L, ASAT ULN: 0.60 µkat/L and ALAT ULN: 0.75 µkat/L) at the screening visit.
  • Females of child-bearing potential* must agree to the use of effective contraception** or practice abstinence during the study and for 30 days after the IMP administration.
  • Adequate haematological function: haemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.3x109 /L and platelet count ≥ 100 x 109 /L.
  • A female of child-bearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. had had menses at any time in the preceding 24 consecutive months).
  • Effective contraception is defined as contraceptive methods with a failure rate of < 1% to prevent pregnancy (combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD]or intrauterine hormone-releasing system [IUS]).

Who cannot join

  • Female patients who are pregnant or who are currently breast feeding.
  • Conditions contraindicating MRI including, but not limited to, body mass index (BMI) > 40 kg/m2 at screening claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric pacemaker, bladder stimulator, pacemaker, defibrillator, artificial valves in heart, aneurysm clips, etc.), and permanent makeup or tattoos which in the Investigator's opinion might jeopardise the patient's safety or interfere with the imaging measurements. The Investigator is encouraged to contact the MR clinic for advice on which implants, tattoos, etc may be unsuitable.
  • Other malignancy than breast and pancreatic cancer within the past 5 years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
  • Moderate to severe hypertension as judged by the Investigator.
  • History of significant cardiovascular disease such as myocardial infarction, congestive heart failure, stroke, serious cardiac arrhythmias. History of angina within 6 months prior to screening.
  • Clinically diagnosed obstruction of bile duct as judged by investigator.
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  • Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting electrocardiogram (ECG) at the time of screening, as judged by the Investigator.
  • Abnormalities detected during examination at screening and admission, which in the opinion of the Investigator, may either put the patient at risk because of participation in the study or influence the results or the patient's ability to participate in the study.
  • Active infection requiring systemic treatment within one week prior to agent administration.
  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
  • Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibodies.
  • Any use of alcohol within 24 hours of admission to the clinic.
  • Plasma donation within 1 month of screening or any blood donation or corresponding blood loss during 3 months prior to screening.
  • Use of investigational agent within four weeks before Visit 1 or plans to initiate treatment with an investigational agent during the study.

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Gothia Forum Clinical Trial Center

    Gothenburg, SE-41345

  • CTC Clinical Trial Consultants AB

    Uppsala, SE-75185

Other trials in Sweden

About this study

Official title: A First-in-human Clinical Evaluation of the Novel Intravenous Contrast Agent SN132D in Patients With Breast and Pancreatic Cancer

This phase I, first-in-human (FIH) study is open-label, non-randomised and non-placebo-controlled. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single intravenous dose of SN132D in approximately 24 patients with breast and pancreatic cancer. Magnetic resonance imaging (MRI) will be performed pre- and post-infusion of SN132D.

Being tested
SN132D
Medical subject headings
Breast Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • SN132DDrug

    Novel manganese-based macromolecular MRI contrast agent

Study groups in NCT04080024
Study groupRoleWhat they receive
Single dose (i.v.) SN132DExperimentalNot described
Receives: Drug: SN132D

What is being measured

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

  1. Number of treatment related adverse events (AEs)

    Frequency, severity and seriousness of AEs including clinically significant changes in physical examinations, safety laboratory parameters, vital signs, electrocardiograms and injection site reactions will be assessed.

    Measured: Baseline up to 2 weeks

Secondary outcomes (8)

  1. Preliminary efficacy (MRI enhancing effect)

    Preliminary efficacy will be evaluated by assessing changes between pre-dose images and post-dose images acquired using T1-weighted imaging sequences, analysing contrast-to-noise in primary tumour vs reference tissue, signal-to-noise in primary tumour, contrast-to-noise in liver and pancreas vs reference tissue and signal-to-noise in liver and pancreas. Additionally, Changes between pre-dose T1 and post-dose T1 in liver and pancreas will be analysed. In pancreatic cancer patients, presence or absence of liver metastases and a number of lesions and diameter of smallest and largest lesion in liver will also be analysed.

    Measured: Day 1

  2. Pharmacokinetics as measured by area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC0-t) for manganese (Mn) (mM x min)

    Samples for pharmacokinetic analysis will be collected at predose and at 10 min, 20 min, 60 min, 65 min, 75 min, 90 min, 105 min, 3 h and 9 h post start of dosing.

    Measured: Baseline up to Day 2

  3. Pharmacokinetics as measured by area under the plasma concentration-time curve from time 0 extrapolated to infinite time (AUCinf) for Mn (mM x min)

    Samples for pharmacokinetic analysis will be collected at predose and at 10 min, 20 min, 60 min, 65 min, 75 min, 90 min, 105 min, 3 h and 9 h post start of dosing.

    Measured: Baseline up to Day 2

  4. Pharmacokinetics as measured by maximum plasma concentration (Cmax) for Mn (µg Mn/mL)

    Samples for pharmacokinetic analysis will be collected at predose and at 10 min, 20 min, 60 min, 65 min, 75 min, 90 min, 105 min, 3 h and 9 h post start of dosing.

    Measured: Baseline up to Day 2

  5. Pharmacokinetics as measured by time to Cmax (Tmax) for Mn (h)

    Samples for pharmacokinetic analysis will be collected at predose and at 10 min, 20 min, 60 min, 65 min, 75 min, 90 min, 105 min, 3 h and 9 h post start of dosing.

    Measured: Baseline up to Day 2

  6. Pharmacokinetics as measured by plasma elimination half-life (T½) for Mn (h)

    Samples for pharmacokinetic analysis will be collected at predose and at 10 min, 20 min, 60 min, 65 min, 75 min, 90 min, 105 min, 3 h and 9 h post start of dosing.

    Measured: Baseline up to Day 2

  7. Pharmacokinetics as measured by total body clearance (CL) for Mn (L/h)

    Samples for pharmacokinetic analysis will be collected at predose and at 10 min, 20 min, 60 min, 65 min, 75 min, 90 min, 105 min, 3 h and 9 h post start of dosing.

    Measured: Baseline up to Day 2

  8. Pharmacokinetics as measured by apparent volume of distribution at steady state (Vss) for Mn (L) the terminal phase half-life (T½) for manganese (Mn)

    Samples for pharmacokinetic analysis will be collected at predose and at 10 min, 20 min, 60 min, 65 min, 75 min, 90 min, 105 min, 3 h and 9 h post start of dosing.

    Measured: Baseline up to Day 2

Timeline

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

  1. First posted6 Sep 2019
  2. Study start23 Aug 2019
  3. Primary completion30 Nov 2022
  4. Study completion30 Nov 2022

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080024
Sponsor's protocol ID
SN132D CSP final version 6.0
Other IDs
2018-002193-41, 2018
Acronym
SPAGOPIX-01
Status last verified
Dec 2022
First submitted
27 Aug 2019
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SN132D in people with Breast Cancer and Pancreas Cancer, run by Spago Nanomedical AB at 2 sites in Sweden.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of treatment related adverse events (AEs) (time frame: Baseline up to 2 weeks). 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 NCT04080024.

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 9 Dec 2022.

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