Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC

NCT07155850 | Recruiting

• 1 other identifier: CIP-PDAC-25-01
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this clinical investigation is to learn if a new type of radiotherapy works to treat pancreatic cancer that cannot be removed surgically. It will also learn about the safety of the new treatment when combined with chemotherapy. The treatment involves injecting a radioactive implant (medical device) directly into the pancreatic tumour on one occasion only. The main questions it aims to answer are:

• Is the new treatment safe and tolerable when used in combination with standard of care chemotherapy.
• Is it feasible to inject the new treatment directly into a patient's pancreatic tumour.
• What is the impact of this new treatment on a patient's quality of life including a pain evaluation.
• To assess how the pancreatic tumour responds to the treatment during the 3 month follow up. Participants will:
• Participate in the research study for approximately 7 months and will receive standard of care chemotherapy throughout their participation.
• Participants will initially receive standard of care chemotherapy which will be stopped after 2 months to reassess the tumor by a multidisciplinary tumor board. Chemotherapy will resume and the test device will be administered between chemotherapy treatments. The new treatment involves a single injection of the radioactive implant directly into the pancreatic tumour. Following treatment, the participant's standard of care chemotherapy will resume.
• Participants will attend follow up visits over 3 months.
• Participants will visit the clinic on 8 separate occasions and on one occasions, will remain in hospital for 2 nights/3 days to receive treatment with the new radiotherapy device and to monitor for safety.
• Participants will complete questionnaires to check how the treatment is affecting their daily lives and pain levels.
• Participants will undergo different types of imaging (scans) such as CT, MRI.
• Participants will have bloods and urine taken to monitor safety.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC); Locally Advanced; Unresectable

Keywords

LA-PDAC; Yttrium-90; YntraDose™

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability assessment

  The primary endpoint is safety and tolerability and will be measured by the frequency of treatment-emergent adverse events (TEAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v5.0).

  From commencement of induction chemotherapy (immediately following screening) to the end of the follow up period at 3 months.

• Feasibility of administration of the medical device

  To evaluate the feasibility of YntraDose™ percutaneous administration under US/CT guidance for implant in the target tumour lesion, without major clinical complications defined as needing medical intervention to resolve any significant adverse event or medical issue arising from the administration of YntraDose™.

  From implantation of the medical device to the end of the follow up period at 3 months.

Secondary Outcomes (4)

• Patient Quality of Life

  From enrollment to the end of the follow up period at 3 months.

• Pain Assessment

  Pain assessments will be collected during the 2 pre-implantation screening visits and at 1 week, 1 month, 2 months and 3 months following implantation of the investigational device.

• Patient tumour response following treatment with the medical device

  From baseline assessments to the end of the follow up period at 3 months.

• Metabolic tumour response evaluation

  From baseline to the to the end of the follow up period at 3 months.

Study Arms (1)

YntraDose™ implantation

EXPERIMENTAL

YntraDose™ is a single use radiotherapy medical device containing Yttrium-90 microspheres administered intratumourally and percutaneously into the pancreas

Device: Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas

Interventions

Medical device containing Y-90 microspheres delivered intratumorally and percutaneously into the pancreas DEVICE

YntraDose™ is a locoregional therapy device used for percutaneous radio-ablation of solid tumours

YntraDose™ implantation

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically proven Pancreatic Adenocarcinoma.
• Stage of disease defined as unresectable Locally Advanced Pancreatic Cancer.
• No prior radiotherapy for pancreatic cancer.
• Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice.
• Life expectancy of ≥6 months at screening.

You may not qualify if:

• Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT/MRI/18 FDG PET assessment.
• Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy.
• More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and/or decision made by the local MDTB.
• ECOG is higher than 1.
• History of malignancy in the last 3 years.
• Blood clotting disorders (INR \> 1.5, PLT \< 50,000/µl - risk of bleeding during organ puncture).
• Active systemic or local infection (e.g. peritonitis, abscess).
• Severe organ failure (e.g. end-stage liver, kidney, heart failure).
• Cardiological and other diseases that threaten the use of anesthesia.
• Pancreatitis (acute or exacerbation of chronic inflammation).

Sponsors & Collaborators

• BetaGlue Therapeutics SpA: lead

Study Sites (2)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Roma, Italy

RECRUITING

Guy's & St Thomas' and Kings College Hospitals

London, United Kingdom

RECRUITING

Central Study Contacts

Carol Hegarty, PhD

CONTACT

+44 7752 303229; c.hegarty@betaglue.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking for either the patient or user
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentre, open-label, prospective, early feasibility clinical investigation to assess the safety, tolerability and feasibility of YntraDose™ treatment following percutaneous administration under US/CT guidance.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 4, 2025
• Study Start: February 3, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: As required, a copy of the final Clinical Investigation Report and a summary of the results written in a manner that is understandable to lay persons, will be provided to the Regulatory Authority and/or Ethics Committee responsible for each participating site within 1 year (12 months) from study completion.
• Access Criteria: Regulatory Authorities and/or Ethics Committees responsible for each investigational site will receive the clinical investigation report and lay person summary. Results will be posted on clinicaltrials.gov which is a publicly accessible database, 12 months following study completion.

Locations

IT (1); GB (1)