A phase 1/2 clinical trial investigating valemetostat (DS-3201b), a dual EZH1/2 inhibitor, combined with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) is going to start to recruit participants. This study aims to evaluate the safety, tolerability, and preliminary efficacy of the combination in men whose disease has progressed despite prior androgen receptor pathway inhibitors (ARPIs). […]
A pivotal clinical trial is underway to evaluate the safety and efficacy of combining Lutetium (177Lu) DGUL radioligand therapy with pembrolizumab (Keytruda) for treating metastatic castration-resistant prostate cancer in patients who have progressed after androgen receptor-targeted therapies but have not yet received chemotherapy. The study enrolls men with prostate-specific membrane antigen (PSMA)-positive tumors, with disease […]
GTB-5550, a novel tri-specific natural killer (NK) cell engager drug designed to target the B7-H3 antigen has shown notable promise in advancing cancer immunotherapy for solid tumors, particularly prostate cancer and head and neck squamous cell carcinoma (HNSCC). This drug functions by simultaneously binding to CD16 on NK cells, engaging B7-H3 expressed on tumor cells, […]
A pivotal new Chinese phase 3 clinical trial is poised to begin recruiting patients with metastatic hormone-sensitive prostate cancer to compare two leading androgen receptor antagonists head-to-head: rezvilutamide (SHR3680) versus enzalutamide in mHSPC. This trial represents an important milestone in prostate cancer therapeutics by directly evaluating the efficacy and safety of these oral treatments in […]
This Phase II study investigates the efficacy and safety of three investigational agents: SHR3680 (rezvilutamide), HS-20093, and SHR2554, aiming to enhance outcomes in metastatic prostate cancer through dual-pathway inhibition. SHR3680, a selective androgen receptor (AR) antagonist, represents the latest generation of hormonal therapy designed to inhibit the AR signaling axis, a critical driver of prostate […]
Australian Human Research Ethics Committee has approved the initiation of a first‑in‑human Phase 1 therapeutic trial of RAD 402, a KLK3 (PSA)‑targeting monoclonal antibody labeled with terbium‑161 for patients with metastatic or locally advanced prostate cancer. The approval positions the program to begin site activation and enrollment in Australia, marking a notable milestone for a […]
Phase II EVOLUTION is a randomized study testing whether adding ipilimumab and nivolumab to 177Lu‑PSMA‑617 improves outcomes versus 177Lu‑PSMA‑617 alone in men with metastatic castration‑resistant prostate cancer (mCRPC). Early data presented in 2025 indicate that at 12 months, 33% of patients on the combination were free of progression versus 17% on 177Lu‑PSMA‑617 alone, signaling a […]
The ongoing phase Ib/II trial investigating the combination of AMO959, Pluvicto (lutetium-177 vipivotide tetraxetan, also known as AAA617 or 177Lu-PSMA-617), and androgen receptor pathway inhibitors (ARPIs) in metastatic castration-resistant prostate cancer (mCRPC) explores a novel approach targeting disease through multiple pathways. AMO959 is a direct activator of AMPK, a key metabolic regulator that can disrupt […]
To join the phase 2 POSTPONE trial investigating pacritinib for advanced prostate cancer, patients must have metastases that are strongly positive for STAT5 activation—specifically, a recent tumor biopsy must show detectable nuclear STAT5 in more than 5% of cancer cells. This trial is built upon robust laboratory and clinical findings showing that the JAK2-STAT5 pathway […]
Pasritamig is a bispecific T-cell engager that targets human kallikrein 2 (KLK2), a protein found primarily in prostate tissue and often retained in advanced prostate cancer. This drug brings T cells into close contact with KLK2-expressing tumor cells, directing immune responses against the cancer. In phase 1 studies, pasritamig was evaluated in men with metastatic […]
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