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.

NCT04632199 | Withdrawn Phase 1 DMC

• 2 other identifiers: D-FR-01087-0022019-002882-37
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 5

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent adverse events

  Safety and Tolerability

  From baseline until the end of study (12 months)

Secondary Outcomes (16)

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

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

• Maximum uptake by source region and the entire body

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

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

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

• Absorbed Radiation doses per organ

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

• Specific absorbed radiation doses per organ

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

Study Arms (2)

111In-IPN01087 Low dose

EXPERIMENTAL

Single intravenous injection of 220 MBq 111In-IPN01087 with a low mass dose of IPN01087

Drug: 111In-IPN01087 Low dose

111In-IPN01087 High dose

EXPERIMENTAL

Single intravenous injection of 220 MBq 111In-IPN01087 with a high mass dose of IPN01087

Drug: 111In-IPN01087 High dose

Interventions

111In-IPN01087 Low dose DRUG

Administered once via slow intravenous injection.

111In-IPN01087 Low dose

111In-IPN01087 High dose DRUG

Administered once via slow intravenous injection.

111In-IPN01087 High dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to the investigational imaging product (IIP) or its excipients administered in this study.
• 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 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (5)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Léon Bérard

Léon, 69008, France

Location

CHRU de Nancy - Hôpital de Brabois

Nancy, 54511, France

Location

CHU de Nantes - Hôpital Hôtel Dieu

Nantes, 44087, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 17, 2020
• Study Start: March 12, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); FR (3)