7 Patients
treated with YntraDose® (previously named BAT-90) in unresectable hepatocellular carcinoma (HCC)
Evidence
A growing body of evidence
YntraDose® has progressed from preclinical validation into first-in-human studies, with published data at each stage and a Phase 1 (Early Feasibility Study) now under way.
- Preclinical validation — Completed. In vivo models of performance and safety, including a large animal model of pancreatic cancer.
- First-in-human studies — Completed. Two studies across two tumor types — unresectable hepatocellular carcinoma (7 patients) and DCIS (13 patients).
- Published clinical data — Published. Peer-reviewed and conference publications covering the platform, its formulation and its early clinical use.
- Phase 1 (Early Feasibility Study) — Under way. The YntraDose® LA-PDAC study is open to recruitment.
- Combination studies — Planned. A randomised Phase 2 evaluating YntraDose® alongside systemic therapy.
Clinical proof of concept
A clinical foundation, building toward Phase 2
YntraDose® (previously named BAT-90) has been evaluated in two first-in-human studies across two tumor types, establishing an early clinical foundation for development in locally advanced pancreatic cancer.
BetaGlue conducted two
FIH clinical studies
13 Patients
treated with YntraDose® (previously named BAT-90) in DCIS (Stage 0/1/2A)
Early clinical signal (HCC)
In the HCC study (7 patients; published poster, J Vasc Interv Radiol 2023), YntraDose® showed a favourable early safety profile — no treatment-limiting complications and no leakage of radioactivity at 24 and 48 hours, with no clinically meaningful change in serum liver enzymes. Early imaging endpoints were encouraging.
These are early data from a small first-in-human study. They are presented as a clinical signal supporting further development and do not establish the efficacy of YntraDose®, which remains investigational.
Development roadmap
A defined path to randomised Phase 2
A Phase 1 (Early Feasibility Study) is now underway, establishing the foundation for Phase 2 combination studies.
Q2 2026
Phase 1 launch UK Belgium Italy
Q3 2026
First patients implanted
H2 2027
Randomised study
YntraDose® is an investigational radiotherapeutic. Its safety and performance are being evaluated in clinical development and have not been established.
The impact of the clinical benefits for patients thanks to this new personalised radiotherapeutic treatment option are potentially broad.
Thanks to the targeted and localized direct intratumoral application of YntraDose, not only is the product relatively simple to use, but more importantly, there is the opportunity to reach lesions in a wide range of anatomies and therefore open the door to benefit many solid tumor cancer patient groups worldwide.
Prof. Jafar Golzarian
Clinical advisor, oncology
At the very beginning of the history of Interventional Oncology, ethanol injection, the only modality available at that time, was rather impressive, given that with simple percutaneous injections it allowed to achieve outcomes comparable to those of complex surgical procedures, albeit in selected cases.
The new technology of YntraDose, using Y-90, seems to be the natural evolution of the old ethanol injection, but applicable in a wide range of neoplastic diseases of different organs, with single applications and greater precision of guidance, given the great progress of imaging modalities. In summary, an actual ‘targeted therapy’ extensively feasible.
Prof. Luigi Solbiati
Nuclear medicine physician
Pre-clinical & Clinical
Publications
- Modelling a new approach for radio‑ablation after resection of breast ductal carcinoma in‑situ based on the BAT‑90 medical device.
- A Novel Injectable Hydrogel Matrix Loaded with 90Y Microspheres for the treatment of Solid Tumours.
- In-vivo models for the performance and safety of BAT-90, a novel 90-Yttrium-based internal radiotherapy platform.
- Preclinical study of safety and efficacy in vivo of a yttrium-90 resin microspheres glue formulation in a large animal model of pancreatic cancer.
- Clinical Percutaneous image-guided radio-ablation using BAT-90 – initial results of ongoing first-in-man clinical trial.
Scientific context
- Hu T, Mo T, Wang L, et al. KRASG12D inhibition reprograms the tumor-induced immunosuppressive environment and enhances NK cell–mediated antitumor immunity.
- Tat CL, Rajapakshe K, Rodriguez E, Bernard-Pagan V. Targeting pancreatic cancer with combination RAS inhibition and radiation therapy.
- Wang T, Wang L, Xu J, et al. Concurrent stereotactic body radiation therapy and KRAS inhibition synergistically improve pre-clinical pancreatic cancer treatment.
- Wang T, et al. Concurrent mutant KRAS inhibition and stereotactic body radiation therapy improve local tumour control in pancreatic cancer.
Selected publications from the wider field. These are not YntraDose® data — they are provided as scientific context for combination strategy in pancreatic cancer.