Tag Archive for: radioligand therapy

Phase 2 Trial: Adaptive PSMA-PET–Guided 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in mHSPC

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The OPTIMAL-e trial is a phase 2 pilot study testing adaptive, PSMA-PET–guided radioligand therapy (RLT) with 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in men with metastatic hormone-sensitive prostate cancer (mHSPC), on top of standard androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI). Conducted at St Vincent’s Hospital in Sydney, it is single-arm, open-label, and nonrandomized, designed […]

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Phase 1 Trial for a New PSMA Radioligand 177Lu‑PSMA‑VG01

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177Lu‑PSMA‑VG01 is a next‑generation, small‑molecule PSMA‑targeting radiopharmaceutical designed to refine what 177Lu‑PSMA‑617 (Pluvicto) has already achieved. It uses a high‑affinity ligand to deliver the beta‑emitter lutetium‑177 directly to PSMA‑expressing tumor cells, aiming for greater tumor dosing with less exposure of healthy tissue. A new phase 1 trial is testing its dosimetry and side effects on […]

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Phase 2 Trial for 61Cu-NU101 vs 18F-Piflufolastat in Metastatic Prostate Cancer

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61Cu-NU101 is a new PSMA-targeted PET/SPECT tracer for prostate cancer that showed promise in phase 1, detecting more lesions than 18F-piflufolastat (Pylarify) in half of the 8 patients studied, with lower background uptake and no side effects. The key advantage is its 3.3-hour half-life, compared to 68 minutes for 68Ga-PSMA-11 and 109 minutes for 18F-piflufolastat. […]

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CD46 ImmunoPET in mCRPC: A New Theranostic Axis Beyond PSMA

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CD46 is a cell‑surface protein that stays highly expressed in aggressive, late‑stage prostate cancer, including PSMA‑low, AR‑negative and neuroendocrine variants. That means CD46 immunoPET can still “see” and quantify disease that PSMA PET misses, and can guide CD46‑targeted therapies in exactly those PSMA‑low/negative patients who respond poorly to PSMA‑directed radioligand therapy. Using the human antibody […]

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Phase 1 Trial: Next-Gen PSMA Radioligand 177Lu-LNC1011 Shows Favorable Results

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177Lu-D-Dan-Phe-PSMA, also called 177Lu-LNC1011, represents a next-generation PSMA-targeted radioligand therapy designed to improve on existing options like Pluvicto for metastatic castration-resistant prostate cancer (mCRPC). Unlike Pluvicto, which clears rapidly through the kidneys and limits sustained tumor exposure, this agent incorporates a dansyl modification for prolonged intratumoral retention while preserving systemic clearance. Early phase 1 results […]

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Three Targets Beyond PSMA in Prostate Cancer Radioligand Therapy

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Radioligand therapy transformed advanced prostate cancer care with PSMA targeting. Now experts eye options for PSMA-resistant or low-expression cases. At APCCC 2026, Dr. Ken Herrmann named ACP3, B7-H3, and STEAP1/STEAP2 as top priorities. These could reach patients (outside clinical trials) in four to five years. ACP3, or prostatic acid phosphatase, binds tighter than PSMA in […]

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AKY-2519: Phase 1b Trial Targets B7-H3 in Metastatic Prostate Cancer

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AKY-2519, a miniprotein radioconjugate targeting B7-H3, has entered a Phase 1b clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC). The open-label study enrolls both PLUVICTO-naïve and PLUVICTO-experienced patients at multiple U.S. radioligand therapy centers, evaluating three dose levels in each cohort before expanding at selected doses. Preliminary safety and efficacy data from this […]

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TLX597-Tx Shows Early Promise in a Phase 2 PSMA Trial for Prostate Cancer

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TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) is emerging as a next-generation PSMA-targeted radioligand therapy designed to deliver radiation more precisely to prostate cancer cells while limiting exposure to healthy organs. New data from the OPTIMAL-PSMA trial suggest that the drug may achieve strong tumor uptake with relatively low dose to the salivary glands and kidneys, two of the main […]

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CEACAM5 Radiotheranostics: A Targeted Strategy for PSMA-Negative, Neuroendocrine Prostate Cancer

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For prostate cancer patients with low expression of PSMA or with neuroendocrine prostate cancer or NEPC (a population growing in size precisely because better treatments are forcing tumors to adapt), a new preclinical study offers a credible precision-targeted strategy: a radiotheranostic pair built on the CEACAM5 surface antigen that produced complete tumor responses in every […]

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ctDNA and Fragmentomics Reveal New Predictors of Survival in 177 Lu-PSMA–617 mCRPC

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Metastatic castration-resistant prostate cancer (mCRPC) remains one of the most challenging stages of prostate cancer, marked by poor prognosis and limited durable treatment options. The radioligand therapy 177Lu-PSMA-617 (Pluvicto) has emerged as a significant advance, demonstrating an overall survival benefit in selected patients. However, clinical responses vary widely, highlighting an urgent need for biomarkers that […]

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