Telix Begins SOLACE Trial, Dosing First Patient for Metastatic Bone Pain Therapy

Telix Pharmaceuticals has announced the first patient dosing in its Phase 1 SOLACE trial, evaluating TLX090 (¹⁵³Sm-DOTMP), a next-generation therapeutic radiopharmaceutical designed to target pain caused by bone metastases.

TLX090 is designed to deliver targeted radiation to bone tumors while minimizing exposure to surrounding healthy tissues. The SOLACE trial (Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage bone pain) is an open-label Phase 1 study enrolling up to 33 patients with advanced cancers that have spread to the skeleton. The study will assess pharmacokinetics, dosimetry, safety, and pain palliation, with data intended to support regulatory pathways toward approval as a non-opioid pain therapy.

According to Telix, SOLACE aims to demonstrate clinical comparability with legacy samarium-153 agents while improving safety and efficacy. This could establish TLX090 as a viable, systemic alternative for patients with severe metastatic bone pain.

Bone metastases are among the most common and debilitating complications of advanced cancer, affecting roughly 400,000 new patients annually. Up to 90% of patients with metastatic prostate cancer experience painful osteoblastic lesions, which significantly impair quality of life.

Despite existing options, such as opioids and external beam radiation therapy (EBRT), many patients remain undertreated. Opioids bring risks of dependency and side effects, while EBRT’s localized approach limits its use for widespread or multifocal pain.

TLX090 offers a potentially cost-effective, systemic, and repeatable treatment option capable of providing up to three to four months of pain relief from a single dose. An earlier study demonstrated a favorable safety profile and early efficacy signals. The cold-kit formulation and pharmacy-based distribution model may also streamline access compared to legacy radiopharmaceuticals.

“We are proud to support the SOLACE trial, which brings new hope to patients living with metastatic bone pain,” said Julio A. Peguero, MD, Medical Director of Research at Oncology Consultants, Houston. “Existing treatments often fall short—whether through limited effectiveness, incomplete pain relief, or burdensome side effects.”

David N. Cade, MD, Telix’s Group Chief Medical Officer, added, “TLX090 has the potential to bridge cancer treatment and quality-of-life care by offering a single-dose, systemic option addressing a significant unmet need across multiple cancer types.”