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WITHDRAWNPHASE1

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 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.

NCT04632199•Ipsen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+10 more criteria

Exclusion Criteria

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

Locations (5)

Institut Jules Bordet

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Centre Léon Bérard

Léon, France

CHRU de Nancy - Hôpital de Brabois

Nancy, France

CHU de Nantes - Hôpital Hôtel Dieu

Nantes, France

Key Dates

Start Date

March 12, 2021

Primary Completion Date

December 10, 2021

Completion Date

December 10, 2021

Last Updated

August 24, 2022

Conditions

Pancreatic Ductal AdenocarcinomaColorectal Cancer

Interventions

111In-IPN01087 Low dose

DRUG

111In-IPN01087 High dose

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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