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

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 […]

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

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 […]

Phase 2 ARTEMIS-003 Trial: HS-20093 for mCRPC

HS-20093  has received Breakthrough Therapy designation from China’s National Medical Products Administration for metastatic castration-resistant prostate cancer. The designation covers patients previously treated with novel endocrine therapy and taxane-based chemotherapy, a setting where later-line treatment options remain limited. HS-20093 is a B7-H3-targeted antibody-drug conjugate designed to bind tumor cells expressing B7-H3 and deliver a cytotoxic […]

Phase 1 Study of BPX-601: A Controlled Immune Therapy for Advanced Prostate Cancer

A new clinical trial has recently begun for a promising but complex type of cancer treatment called BPX-601, designed specifically for men dealing with advanced prostate cancer that has stopped responding to traditional therapies. This therapy is a form of CAR T-cell treatment, which means doctors take a patient’s own immune cells, reprogram them in […]

Double-Masked PSMA-TCE JANX014 Enters Phase 1 for mCRPC

A novel double-masked T-cell engager targeting prostate-specific membrane antigen (PSMA), called JANX014, has entered phase 1 testing in patients with metastatic castration-resistant prostate cancer (mCRPC). The first-in-human, open-label, multicenter trial, which dosed its initial participant in mid-April 2026, evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, and early antitumor activity through ascending intravenous doses administered as monotherapy to […]

Phase 1/2 RAISIC‑1 Trial: PTT‑4256 in Advanced Solid Tumors

PTT‑4256 is an emerging first‑in‑class small‑molecule inhibitor of GPR65, a proton‑sensing G‑protein‑coupled receptor selectively expressed on immune cells within the acidic tumour microenvironment. It is being evaluated in the RAISIC‑1 trial, a modular, open‑label, phase 1/2 study in patients with advanced solid tumours designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy. The trial’s […]

Phase 1/2 Trial for AZD8359: a CD8-Biased T Cell Engager Targeting STEAP2 in m CRPC

Bispecific T cell engagers, while conceptually powerful, have carried a toxicity profile that constrains their clinical utility. AZD8359, a novel trispecific T cell engager now entering its first-in-human clinical trial, represents a thoughtful attempt to resolve that toxicity problem at the molecular engineering level, and its preclinical data are among the most compelling seen in this […]

UPDATE: Phase 1 Trial of HSK46575, a Novel CYP11A1 Inhibitor for Advanced Prostate Cancer

HSK46575, a novel CYP11A1 inhibitor designed to suppress the entire steroidogenesis pathway, continues to generate interest in advanced prostate cancer, with new early-phase clinical data providing a clearer picture of its activity and tolerability in patients. At the latest data cut-off, 27 patients with advanced prostate cancer had been treated across dose-escalation cohorts ranging from […]

DLL3-Targeted ADC ZL-1310 Shows Early Promise in Neuroendocrine Carcinomas

Early-phase data from the ZL-1310-002 trial introduce a potentially important new therapeutic option for patients with advanced neuroendocrine carcinomas (NECs), a group of aggressive malignancies with very limited treatment options after platinum-based chemotherapy. Among these, neuroendocrine prostate cancer (NEPC) represents one of the most clinically challenging subtypes, characterized by rapid progression, resistance to androgen receptor–targeted […]

Early Results for ACE‑106 (ACE‑86225106): A Selective PARP1 Inhibitor for HRR‑Mutant Cancers

ACE‑106 (ACE‑86225106) is a highly selective PARP1 inhibitor designed to improve the therapeutic index compared with first‑generation pan‑PARP inhibitors, which broadly inhibit both PARP1 and PARP2 while causing substantial hematologic toxicity. The updated first‑in‑human data from the open‑label, dose‑escalation study show that ACE‑106 is well tolerated, with no dose‑limiting toxicities, no grade 4–5 treatment‑related adverse […]