Tag Archive for: radioligand therapy

ANDROMEDA Trial: Alpha vs. Beta PSMA Therapy

The ANDROMEDA phase 2 trial represents an advancement in managing recurrent oligometastatic prostate cancer by directly pitting alpha-emitting 225Ac-PSMA-617 against the established beta-emitting 177Lu-PSMA-617 (Pluvicto), both combined with stereotactic body radiotherapy (SBRT). This head-to-head comparison stems from the need to address limitations in current therapies for patients whose cancer returns in 1-5 detectable spots on […]

Actinium‑225 NTSR1‑Targeted Radiopharmaceutical SKL35501

SKL35501 is an emerging radiopharmaceutical therapy that embodies much of what “next‑generation oncology” is supposed to mean: precise targeting, potent cell kill, and a built‑in companion diagnostic strategy. In January 2026, the US FDA cleared SKL35501 and its imaging partner SKL35502 for a phase 1 Investigational New Drug (IND). SKL35501 originated as FL‑091, a small‑molecule […]

UPDATE: SECuRE Trial Phase 2 Shows 67% PSA50 Response in Heavily Pre-Treated mCRPC

The latest interim update from the SECuRE trial reinforces the impression that copper‑67 PSMA targeting is emerging as a credible contender in the mCRPC radioligand space, with consistent PSA responses and a clean safety profile in a small but challenging population. The Safety Review Committee has endorsed continuation of the Phase 2 cohort expansion without […]

PSMA-1-DOTA: A New Ligand to Make Prostate Cancer Radioligand Therapy More Targeted

PSMA-targeted radioligand therapy (RLT) has transformed treatment for end-stage prostate cancer, offering strong tumor control in patients who have exhausted other options. However, these therapies frequently cause severe salivary gland damage, leading to debilitating dry mouth that often forces patients to stop treatment early. To overcome this, researchers at Case Western Reserve University developed PSMA-1-DOTA, […]

HRS-4357, a Novel PSMA-targeted Radiologand Therapy Phase 3 Trial

HRS-4357, a novel PSMA-targeted radiopharmaceutical, is poised to enter a landmark Phase III clinical trial targeting metastatic castration-resistant prostate cancer (mCRPC). The trial, received approval from China’s National Medical Products Administration on December 23, 2025, and plans to enroll 370 patients across multiple centers in China. This randomized, open-label, controlled study will directly compare HRS-4357 […]

ADVC001: Lead-212 PSMA Alpha Therapy Shows Safety and Efficacy in mCRPC Trial

At the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, new clinical data from a Phase 1b dose escalation trial investigating ADVC001, a novel Lead-212-based PSMA-targeted alpha therapy for metastatic castration-resistant prostate cancer (mCRPC) was presented. The therapy utilizes a radioactive isotope, Lead-212, to deliver targeted alpha radiation to prostate cancer cells, aiming […]

UPDATE: Phase 1 Trial of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

A new Phase 1 clinical study, known as the ARTISAN trial, is evaluating an investigational lead-212 alpha radioligand therapy targeting prostate-specific membrane antigen (PSMA) in men with metastatic castration-resistant prostate cancer (mCRPC). We discussed AB001 in a previous article; the trial has now been approved, and its full details are available. The therapy combines a […]

OMNIRAY: a Phase 1 Clinical Trial for LY4257496 for mCRPC

The OMNIRAY trial will be investigating LY4257496, a novel radioligand therapy and it is set to begin in August 2025. This phase 1a/1b, multicenter, open-label study aims to establish the safety, tolerability and dosimetry of LY4257496 in adult patients bearing advanced solid tumors that express the gastrin-releasing peptide receptor (GRPR). The trial proposes a two-part […]