Phase 1 Trial Investigates MAO-A Inhibition With ITR-251 to Overcome Prostate Cancer Resistance

A new Phase 1 clinical trial  will investigate ITR-251, an experimental inhibitor of monoamine oxidase A (MAO-A), as a potential treatment for advanced solid tumours and metastatic castration-resistant prostate cancer (mCRPC). What makes this investigation unusual is its molecular target. MAO-A is an enzyme best known for breaking down neurotransmitters and other monoamines. However, research […]

Phase 1/2 Trial Combines GI-102 With Pasritamig to Strengthen T-Cell Immunotherapy in Advanced Prostate Cancer

A newly registered phase 1/2 clinical trial will investigate whether combining two immunotherapies with complementary mechanisms can improve treatment outcomes in men with metastatic castration-resistant prostate cancer (mCRPC). The study, known as JET-201, plans to enrol 107 patients in the United States and South Korea. The combination brings together pasritamig (JNJ-78278343), a bispecific antibody designed […]

UPDATE: LUNAR Trial Follow-Up Strengthens Case for Earlier PSMA Radioligand Therapy

Longer follow-up from the randomized phase 2 LUNAR trial suggests that PSMA-targeted radioligand therapy may do more than simply delay progression when used early in men with oligorecurrent hormone-sensitive prostate cancer. LUNAR enrolled 92 men whose prostate cancer had returned after previous treatment, with one to five metastases visible on PSMA PET/CT. Importantly, patients were […]

New Randomized Phase 2 Trial Tests Vaccine Plus PSMA×CD3 Immunotherapy in Biochemical Recurrence

A new randomized phase 2 trial will test an immunotherapy strategy specifically in men with biochemical recurrence of prostate cancer after local treatment with curative intent, meaning patients whose PSA is rising again after surgery and/or radiotherapy but who are not yet receiving further systemic treatment. The study plans to enrol up to 84 patients […]

UPDATE: VIR-5500 Receives FDA Fast Track Designation Following Promising Phase 1 Results in mCRPC / mAPMR

The US Food and Drug Administration (FDA) has granted Fast Track designation to VIR-5500 (formerly AMX-500), an experimental immunotherapy for patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC). The designation is intended to accelerate clinical development and regulatory review, but does not constitute drug approval. VIR-5500 is a bispecific T-cell engager designed to direct […]

Phase 1 Trial for KMV002, a New Prostate Cancer Vaccine for mCRPC

A new phase 1  clinical trial will investigate KMV002, an experimental therapeutic cancer vaccine for patients with metastatic prostate cancer that has become resistant to androgen-targeting treatments (mAPMR, previously mCRPC). Patients will receive either five or six doses of KMV002, a combination of SN3001C and an immune-stimulating substance known as a CpG ODN adjuvant. KMV002, […]

UPDATE: ENV-105 Extends Median PFS to 17.7 Months in mCRPC

We updated you about the positive results of carotuximab (ENV-105) in this previous post. Now phase 2 data suggest that ENV-105 combined with apalutamide may substantially delay progression in metastatic castration-resistant prostate cancer (mCRPC) compared with apalutamide alone. In the randomised study, median progression-free survival reached 17.7 months with ENV-105 plus apalutamide, compared with just […]

Phase 3 Trial for 177Lu-ludotadipep Radioligand Therapy for mCRPC

A new phase 3 trial is testing 177Lu-ludotadipep (177Lu-FC705 or, simply, FC705), an experimental PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). Unlike 177Lu-PSMA-617 (Pluvicto), ludotadipep includes an albumin-binding component designed to keep the radioligand in circulation longer and increase radiation delivery to PSMA-positive tumours. Earlier studies suggest that this strategy may allow substantial […]

Phase 2/3 Trial Will Test BAT Followed by Darolutamide

A newly registered randomised phase 2/3trial will test an unusual strategy in metastatic androgen pathway modulation-resistant prostate cancer (mAPMR; formerly mCRPC or castration-resistant prostate cancer): deliberately exposing resistant cancer cells to very high testosterone levels before attacking the androgen receptor again with darolutamide. The study plans to enrol 432 patients with mCRPC who have already […]

Phase 1/2 Trial: REGN21353 Plus Nezastomig STEAP1×CD3 and PSMA×CD28 Combination Enters mCRPC Trials

A new phase 1/2 trial will test REGN21353, a STEAP1×CD3 bispecific antibody, alone and in combination with nezastomig (REGN5678), a PSMA×CD28 costimulatory bispecific, in previously treated metastatic castration-resistant prostate cancer mCRPC (metastatic androgen pathway modulation-resistant prostate cancer mAPMR). The approach combines two different prostate cancer antigens and two complementary immune signals: CD3-mediated T-cell activation through […]