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NOT YET RECRUITING
NCT07555587
PHASE1

Safety and Efficacy of NRT6008 Administered in Combination With Chemotherapy in Patients With Unresectable Locally Advanced Pancreatic Carcinoma (LAPC)

Sponsor: NRT MedTech Australia Pty Ltd

View on ClinicalTrials.gov

Summary

This is a phase Ib, open-label study to evaluate safety and efficacy of NRT6008 in combination with standard-of-care chemotherapy in patients with unresectable Locally Advanced Pancreatic Carcinoma (LAPC).

Official title: A Phase Ib Trial to Evaluate the Safety and Efficacy of NRT6008 Plus Chemotherapy in Unresectable Locally Advanced Pancreatic Carcinoma

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-09

Completion Date

2029-06

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DEVICE

NRT6008 Injection

In this study, all participants shall receive NRT6008 injection (for 200 Gy tumour tissue absorbed dose).

DRUG

Systematic chemotherapy

Participants will be assigned to receive chemotherapy (GN or (m)FOLFIRINOX) at the Investigator's discretion and in accordance with institutional practice. Chemotherapy will be initiated in Cycle 1. The investigational device, NRT6008 Injection, will be administered 10 days (±3 days) after completion of the tumour assessment in Cycle 1. Participants will then receive Cycle 2 Day 1 chemotherapy 7 days (±1 day) following NRT6008 administration. The Investigator-assigned chemotherapy regimen will continue throughout the study until the occurrence of disease progression, intolerance to chemotherapy, death, loss to follow-up, or determination of eligibility for surgical resection (including R0 or R1 resection), whichever occurs first.

Locations (1)

Royal Adelaide Hospital

Adelaide, Australia