YntraDose™ given before chemotherapy for locally advanced, unresectable pancreatic cancer

Early Feasibility Clinical Investigation Using a Novel 90-Yttrium-based Internal Radiotherapy Platform, YntraDose™ in Unresectable Locally Advanced Pancreatic Adenocarcinoma (LA-PDAC) as an add-on Therapy to First-line SOC (Chemotherapy)

This will test whether a one-time, image-guided injection of YntraDose™ (Y-90 radioactive microspheres) into the pancreatic tumor, combined with standard chemotherapy, is safe and can help control locally advanced unresectable pancreatic cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BetaGlue Therapeutics SpA (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Roma and 1 other locations)
• Trial ID: NCT07155850 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label early feasibility investigation enrolls patients with unresectable locally advanced pancreatic ductal adenocarcinoma to receive a single percutaneous, image-guided intratumoral injection of YntraDose™ followed by standard chemotherapy (FOLFIRINOX or gemcitabine/nab‑paclitaxel). YntraDose™ delivers Y-90 microspheres in a glue matrix to localize beta radiation within the tumor and is designed for single-use intratumoral administration under ultrasound/CT guidance. Primary objectives are safety, tolerability and feasibility of percutaneous delivery, with secondary assessments of tumor response, pain, quality of life, and potential conversion to resectability during roughly seven months of participation including a three-month follow-up. Patients will continue standard of care chemotherapy throughout participation and will be monitored with imaging and clinical assessments.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically or cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma, a target tumor of at least 2.6 cm (approximately 9–34 ml), ECOG 0–1, no prior pancreatic radiotherapy, adequate organ function, and able to receive standard chemotherapy.

Not a fit: Patients with distant metastases, tumors outside the specified size/volume window, poor performance status, prior pancreatic radiotherapy, or who cannot undergo percutaneous image‑guided injection or systemic chemotherapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could improve local tumor control, reduce pain, and in some cases convert unresectable tumors to resectable status, potentially improving outcomes.

How similar studies have performed: Locoregional Y-90 therapies have shown promise in liver tumors, but direct intratumoral Y-90 injection for pancreatic cancer is relatively novel with limited prior clinical data.

Eligibility criteria

Inclusion Criteria (Main):

* 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.

Exclusion Criteria (Main):

* 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).

Where this trial is running

Roma and 1 other locations

• Fondazione Policlinico Universitario A. Gemelli, IRCCS — Roma, Italy (RECRUITING)
• Guy's & St Thomas' and Kings College Hospitals — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Carol Hegarty, PhD

Conditions: Pancreatic Ductal Adenocarcinoma, Locally Advanced, Unresectable, LA-PDAC, Yttrium-90, YntraDose™