Clinical Trial 22331

• Overview

  Study Title:

  A Phase I trial to assess safety, tolerability, pharmacokinetics, radiation dosimetry, and positron emission tomography (PET) imaging properties of 89Zr-labelled hNd2 (NMK89) in patients with pancreatic cancer histologically positive for MUC5AC

  Summary:

  Non-randomized, Phase I trial to evaluate safety, tolerability, biodistribution, radiation dosimetry, pharmacokinetics and PET imaging properties following an infusion of 37 MBq (1 mCi) of 89Zr-labeled hNd2* (NMK89) in patients with pancreatic cancer that are positive for MUC5AC. hNd2: Recombinant humanized Nd2 (anti-human MUC5AC monoclonal antibody)

  Objective:

  Primary Objective The primary objective of the trial is to evaluate clinical safety and tolerability of a single infusion of NMK89 in patients with pancreatic cancer histologically positive for MUC5AC. Secondary Objectives 1. To assess biodistribution of NMK89 in normal tissues and tumors in patients with pancreatic cancer. 2. To estimate the whole-body radiation dosimetry of NMK89 in patients with pancreatic cancer. 3. To optimize a PET scan protocol for NMK89 in terms of timing after infusion. 4. To estimate the whole-body radiation dosimetry if hNd2 will be labeled with a therapeutic radionuclide. 5. To determine the pharmacokinetics, distribution and excretion of NMK89 by monitoring concentration of total antibody, total radioactivity counts, and radioactivity counts of NM0047 (89Zr) in acquired urine and blood samples. 6. To assess public safety by acquiring dosimeter readings of a patient following infusion.

• Treatments

  Therapies:

  Antibody-Radionuclide Conjugate

  Medications:

  NMK89 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Willing and able to provide informed consent.
  • Male or female 18 years of age or older.
  • Histologically confirmed diagnosis of pancreatic adenocarcinoma.
  • Willing to provide biopsy specimens for purposes of confirmation of MUC5AC expression.
  • Confirmed MUC5AC expression at pre-screening.
  • Measurable disease.
  • Female patients of child-bearing potential must have a negative serum pregnancy test within 30 days prior to infusion of NMK89.
  • Willing to comply with the study protocol requirements.
  • Willing to provide a tumor resection specimen or biopsy specimen, if the patient undergoes tumor resection or biopsy between Day 16 and Day 60.

• Exclusion Criteria

  Exclusion Criteria:
  • Known hypersensitivity to the investigational medicinal product (IMP) or any of the excipients.
  • History of another primary cancer within the 2 years prior to enrollment, except for the curatively treated in situ cancers.
  • Exposure to any investigational treatments within 30 days prior to the planned date of infusion of NMK89.
  • Ongoing toxicity Grade 2 or higher.
  • Pleural effusion or peritoneal fluid Grade 3 or higher.
  • Active hepatitis B, hepatitis C, HIV, or other progressing infectious disease.
  • Uncontrolled diabetes.
  • Autoimmune disease or idiopathic thrombocytopenic purpura.
  • Exposure to any radiopharmaceuticals.
  • Planned antineoplastic therapies on the planned date of NMK89 infusion.
  • Use of bevacizumab or any other anti-angiogenic agent.
  • Uncontrolled intercurrent illness.
  • Eastern Cooperative Oncology Group (ECOG) PS: 2 or greater.
  • Participants do not have adequate organ and marrow function.
  • Female patients that are pregnant or breast-feeding.
  • Positive urine screen for illegal drugs, or abuse of prescribed drugs at Screening.
  • Participants with contraindications to contrast agent injection used for diagnostic CT.
  • Deemed inappropriate to participate by the investigator.

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