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Not recruiting
Phase 1

89Zr-labeled hNd2

Sponsor:

Nihon Medi-Physics Co., Ltd.

Code:

NCT06129422

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NMK89

Study Details

Brief summary:

This trial will be a 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. Image acquisition is conducted using a PET/CT machine.

\* hNd2: Recombinant humanized Nd2 (anti-human MUC5AC monoclonal antibody)

Conditions

Pancreatic Cancer

Study ID

NCT06129422

Start date

Oct 31, 2023

Status verified date

Jun, 2025

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Willing and able to provide informed consent.
2. Male or female ≥ 18 years of age.
3. Histologically confirmed diagnosis of pancreatic adenocarcinoma.
4. Willing to provide biopsy specimens for purposes of confirmation of MUC5AC expression.
5. Confirmed MUC5AC expression at pre-screening.
6. Measurable disease.
7. Female patients of child-bearing potential must have a negative serum pregnancy test within 30 days prior to infusion of NMK89.
8. Willing to comply with the study protocol requirements.
9. 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:

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: NMK89

Patients will receive a single infusion of NMK89

Interventions

NMK89

Route of administration: intravenous infusion

Primary outcome measure

  • Safety and tolerability of a single infusion of NMK89: physical examination 1 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: physical examination 2 [ Time Frame: Screening ]
  • Safety and tolerability of a single infusion of NMK89: vital sign 1 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: vital sign 2 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: vital sign 3 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: vital sign 4 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: 12-lead ECG (Electrocardiogram) 1 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: 12-lead ECG 2 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: 12-lead ECG 3 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: 12-lead ECG 4 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: 12-lead ECG 5 [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: Frequency and severity of abnormal adverse events (AEs) (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0)) [ Time Frame: Baseline up to Day 60 ]
  • Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - hematology [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - serum chemistry [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - clotting factors [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: Clinical laboratory finding - urinalysis [ Time Frame: Screening to Day 8 ]
  • Safety and tolerability of a single infusion of NMK89: Frequency and severity of abnormal ECOG PS (Eastern Cooperative Oncology Group Performance Status) [ Time Frame: Screening to Day 8 ]

Central Contacts and Locations

Locations

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Clayton McNamara

616-330-2735Clayton.McNamara@bamfhealth.com

Principal Investigator:

Harshad R. Kulkarni, MD

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Heather White

206-667-5534hwhite@fredhutch.org

Principal Investigator:

Delphine Chen, MD

More Information

Sponsor

Nihon Medi-Physics Co., Ltd.

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • pancreatic cancer
  • MUC5AC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Nihon Medi-Physics Co., Ltd. on 2025-06-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.