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Pancreatic Ductal AdenocarcinomaPhase 1NCT04632199

Study to Assess the Safety and Efficacy of Intravenous Injection of the Imaging Agent 111In-IPN01087 in Patients With Locally Advanced or Metastatic Pancreatic or Colorectal Cancer.

A Phase 1 study testing 111In-IPN01087 Low dose and 111In-IPN01087 High dose in people with Pancreatic Ductal Adenocarcinoma and Colorectal Cancer, run by Ipsen at 5 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

111Indium-labelled IPN01087 (111In-IPN01087) is developed as a radioactive diagnostic imaging agent in patients with colorectal or pancreatic cancer. It is used with single-photon emission computed tomography (SPECT) for the identification of tumours that overexpress the neurotensin receptor-1 (NTSR1). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
111In-IPN01087 Low dose and 111In-IPN01087 High dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
5 sitesin 2 countries
Study dates
12 Mar 2021to 10 Dec 2021
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 form prior to all study procedures.
  • Male or female patients ≥18 years.
  • Histologically confirmed locally advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC) or Colorectal cancer (CRC), not amenable to treatment with curative intent.
  • At least one lesion identified by CT or MRI as being ≥2 cm in the longest diameter on axial plane, which has not been previously treated with external beam radiation.
  • Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
  • Estimated life expectancy >3 months.
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  • Clinically acceptable medical history, physical examination and vital signs findings during the screening period
  • Adequate organ function as evidence by: Leukocytes ≥2000/μL, Absolute neutrophil count ≥750/μL, Platelets ≥75,000/μL, Haemoglobin ≥10 g/dL, Total serum bilirubin ≤1.5×upper limit of normal range (or in case of hepatic metastases ≤2.5 x upper limit of normal range), Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3×upper limit of normal range (or in case of hepatic metastases ≤5 x upper limit of normal range), Estimated glomerular filtration rate ≥50 mL/min.
  • Willing and able to comply with study restrictions, including remaining at the clinic for the required time during the study period, and willing to return to the clinic for the follow-up evaluation, as specified in the protocol.
  • For women of childbearing potential (neither surgically sterile nor post-menopausal defined as no menses for 12 months without an alternative medical cause), a negative highly sensitive pregnancy test must be documented at the screening visit (serum test).
  • Female patients of childbearing potential (not surgically sterile or post-menopause defined as no menses for 12 months without an alternative medical cause) must use a medically accepted highly effective method of contraception and must agree to use this method for the duration of the study (from screening until 6 months after administration of 111In-IPN01087).
  • Male patients must agree to use a condom for the duration of the study and for at least 90 days after administration of 111In-IPN01087.
  • Male patients with female partners of childbearing potential must use a medically accepted highly effective method of contraception and must agree to use this method for the duration of the study and for at least 90 days after administration of 111In-IPN01087.

Who cannot join

  • Known allergy to the investigational imaging product (IIP) or its excipients administered in this study.
  • Any newly commenced licensed or investigational anti-cancer therapy within 30 days prior to IIP administration. Therapies started more than 30 days prior to IIP administration can be continued, provided patients have adequate organ function as per inclusion criteria.
  • Receiving, or scheduled to receive, another IIP from 1 month before screening to 1 week after administration of 111In-IPN01087.
  • Administration of any radiopharmaceutical within eight half lives of that radionuclide before IIP administration.
  • Any unresolved NCI-CTCAE Grade 2 or higher (except alopecia or where Grade 3 is permissible as per the inclusion criteria)
  • Any condition that precludes adequate SPECT and/or CT imaging, e.g. patients unable to lie still for the entire imaging time, or metal prosthetics which interfere with CT (hip and knee prosthetics are acceptable).
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  • Clinically significant abnormalities on ECG at screening
  • Any uncontrolled significant medical, psychiatric or surgical condition or laboratory finding that would pose a risk to patient safety, or interfere with study participation, or interpretation of individual patient results.
  • Pregnancy, lactation, or breastfeeding.
  • Unable to understand the nature, scope and possible consequences of the study, in the judgment of the investigator.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

France3 sites

  • Centre Léon Bérard

    Léon, 69008

  • CHRU de Nancy - Hôpital de Brabois

    Nancy, 54511

  • CHU de Nantes - Hôpital Hôtel Dieu

    Nantes, 44087

Other trials in France

Belgium2 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Phase I, Open Label, Study to Assess Safety, Tolerability, Biodistribution, Radiation Dosimetry and SPECT/CT Imaging Characteristics of Intravenous 111In-IPN01087 in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma or Colorectal Cancer.

111Indium-labelled IPN01087 (111In-IPN01087) is developed as a radioactive diagnostic imaging agent in patients with colorectal or pancreatic cancer. It is used with single-photon emission computed tomography (SPECT) for the identification of tumours that overexpress the neurotensin receptor-1 (NTSR1). The purpose of this study is to assess how well 111In-IPN01087 is tolerated and what the most suitable amount to be injected is to obtain good quality images. The study will also look at how 111In-IPN01087 is distributed throughout the body and what the optimal time for doing the scans will be after it has been given as a single intravenous injection.

Being tested
111In-IPN01087 Low dose, 111In-IPN01087 High dose
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • 111In-IPN01087 Low doseDrug

    Administered once via slow intravenous injection.

  • 111In-IPN01087 High doseDrug

    Administered once via slow intravenous injection.

Study groups in NCT04632199
Study groupRoleWhat they receive
111In-IPN01087 Low doseExperimentalSingle intravenous injection of 220 MBq 111In-IPN01087 with a low mass dose of IPN01087
Receives: Drug: 111In-IPN01087 Low dose
111In-IPN01087 High doseExperimentalSingle intravenous injection of 220 MBq 111In-IPN01087 with a high mass dose of IPN01087
Receives: Drug: 111In-IPN01087 High dose

What is being measured

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

  1. Incidence of Treatment-emergent adverse events

    Safety and Tolerability

    Measured: From baseline until the end of study (12 months)

Secondary outcomes (16)

  1. Whole body biodistribution of 111In-IPN01087 using whole body planar imaging

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  2. Maximum uptake by source region and the entire body

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  3. Time-integrated activity coefficients by source region and the entire body

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  4. Absorbed Radiation doses per organ

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  5. Specific absorbed radiation doses per organ

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  6. Organs receiving the highest radiation dose.

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  7. Normalized whole body effective dose

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  8. Total effective dose

    Measured: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4

  9. Optimal imaging time window assessed as maximum tumour contrast on single photon emission computed tomography/computed tomography (SPECT/CT) imaging at all available timepoints post injection

    Measured: Day 1 (6 hours post-dose), Day 2, Day 3 and Day 4

  10. Time for maximal activity in blood

    Measured: Day 1 (pre-dose, immediately after the end of the 111In-IPN01087 injection (Time 0), 30 minutes, 2 hours, 4 hours and 6 hours post-dose), Day 2, Day 3 and Day 4

  11. Area under the time-activity curve from time 0 to the time of the last quantifiable concentration

    Measured: Day 1 (pre-dose, immediately after the end of the 111In-IPN01087 injection (Time 0), 30 minutes, 2 hours, 4 hours and 6 hours post-dose), Day 2, Day 3 and Day 4

  12. Apparent terminal elimination half life

    Measured: Day 1 (pre-dose, immediately after the end of the 111In-IPN01087 injection (Time 0), 30 minutes, 2 hours, 4 hours and 6 hours post-dose), Day 2, Day 3 and Day 4

  13. Cumulative amount of 111In-IPN01087 excreted in the urine over 48 hours

    Measured: From the time of the 111In-IPN01087 injection to 6 hours, from 6 hours to 24 hours and from 24 hours to 48 hours

  14. Fraction of the administered 111In-IPN01087 excreted in urine over 48 hours

    Measured: From the time of the 111In-IPN01087 injection to 6 hours, from 6 hours to 24 hours and from 24 hours to 48 hours

  15. Renal clearance of 111In-IPN01087

    Measured: From the time of the 111In-IPN01087 injection to 48 hours

  16. Optimal injected radioactivity range

    Measured: Day 1 (6 hours post-dose), Day 2, Day 3 and Day 4.

Timeline

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

  1. First posted17 Nov 2020
  2. Study start12 Mar 2021 (estimated)
  3. Primary completion10 Dec 2021 (estimated)
  4. Study completion10 Dec 2021 (estimated)

Why it stopped: Business decision not related to any safety or tolerability concern

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04632199
Sponsor's protocol ID
D-FR-01087-002
Other IDs
2019-002882-37, 2019
Status last verified
Aug 2022
First submitted
23 Oct 2020
Last updated
24 Aug 2022
Results posted
No
Data monitoring committee
Yes
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 111In-IPN01087 Low dose and 111In-IPN01087 High dose in people with Pancreatic Ductal Adenocarcinoma and Colorectal Cancer, run by Ipsen at 5 sites in 2 countries.

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 13 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Belgium. 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 was withdrawn before enrolling participants, so there are no results.

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?

Incidence of Treatment-emergent adverse events (time frame: From baseline until the end of study (12 months)). 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 NCT04632199.

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 24 Aug 2022.

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