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.

• ClinicalTrials.gov Identifier: NCT04632199
• Recruitment Status: Not yet recruiting
• First Posted: November 17, 2020
• Last Update Posted: February 1, 2021
• Sponsor: Ipsen
• Information provided by (Responsible Party): Ipsen

Study Description

Brief 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). 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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Ductal Adenocarcinoma; Colorectal Cancer	Drug: 111In-IPN01087 Low dose; Drug: 111In-IPN01087 High dose	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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.
• Estimated Study Start Date: March 12, 2021
• Estimated Primary Completion Date: December 10, 2021
• Estimated Study Completion Date: December 10, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 111In-IPN01087 Low dose; Single intravenous injection of 220 MBq 111In-IPN01087 with a low mass dose of IPN01087	Drug: 111In-IPN01087 Low dose; Administered once via slow intravenous injection.
Experimental: 111In-IPN01087 High dose; Single intravenous injection of 220 MBq 111In-IPN01087 with a high mass dose of IPN01087	Drug: 111In-IPN01087 High dose; Administered once via slow intravenous injection.

Outcome Measures

Primary Outcome Measures :

1. Incidence of Treatment-emergent adverse events [ Time Frame: From baseline until the end of study (12 months) ]
   Safety and Tolerability

Secondary Outcome Measures :

1. Whole body biodistribution of 111In-IPN01087 using whole body planar imaging [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4 ]
4. Absorbed Radiation doses per organ [ Time Frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4 ]
5. Specific absorbed radiation doses per organ [ Time Frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4 ]
6. Organs receiving the highest radiation dose. [ Time Frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4 ]
7. Normalized whole body effective dose [ Time Frame: Day 1 (30 minutes and 6 hours post-dose), Day 2, Day 3 and Day 4 ]
8. Total effective dose [ Time Frame: 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 [ Time Frame: Day 1 (6 hours post-dose), Day 2, Day 3 and Day 4 ]
10. Time for maximal activity in blood [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From the time of the 111In-IPN01087 injection to 48 hours ]
16. Optimal injected radioactivity range [ Time Frame: Day 1 (6 hours post-dose), Day 2, Day 3 and Day 4. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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).
• 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.

Contacts and Locations

Contacts

Contact: Ipsen Recruitment Enquiries; see email; clinical.trials@ipsen.com

Locations

Belgium

Institut Jules Bordet

Brussels, Belgium, 1000

UZ Leuven

Leuven, Belgium, 3000

France

Centre Léon Bérard

Léon, France, 69008

CHRU de Nancy - Hôpital de Brabois

Nancy, France, 54511

CHU de Nantes - Hôpital Hôtel Dieu

Nantes, France, 44087

Sponsors and Collaborators

Ipsen

Investigators

• Study Director: Ipsen Medical Director; Ipsen

More Information

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT04632199
• Other Study ID Numbers: D-FR-01087-002; 2019-002882-37 ( EudraCT Number )
• First Posted: November 17, 2020
• Last Update Posted: February 1, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
• Time Frame: Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
• Access Criteria: Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colorectal Neoplasms; Adenocarcinoma; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type