Phase 1/2 Trial for GDC‑1261 in Advanced Prostate Cancer

GDC‑1261 is a new study drug being tested in men with advanced or metastatic prostate cancer in a first‑in‑human Phase 1/2 trial. The public description of the study states that the main goals are to evaluate the safety profile, pharmacokinetics, and preliminary anti‑tumor activity of GDC‑1261 and to identify a recommended dose and dosing schedule […]

Phase 1/2 Update: Concurrent Enzalutamide–Cabazitaxel Produces Durable PFS Signal in mCRPC

The updated Phase 1/2 data for concurrent enzalutamide plus cabazitaxel in chemo‑naïve mCRPC show deep biochemical responses and a promising signal for progression‑free outcomes, but the dataset remains hypothesis‑generating. In a multi‑institutional single‑arm trial of enzalutamide with cabazitaxel (plus prednisone), 35 patients were included in the efficacy analysis with a median follow‑up of 23.7 months; […]

UPDATE: PSMA‑Targeted CAR‑NK Cells for mCRPC Shows Promising Results

A new, promising concept was explored for men with metastatic castration‑resistant prostate cancer: PSMA‑targeted CAR‑NK cells engineered to be an off‑the‑shelf immunotherapy that aims to combine targeted tumor killing with a safer toxicity profile. The work, presented at AUA 2026 meeting, comes from investigators affiliated with the Cancer Hospital, Chinese Academy of Medical Sciences, who […]

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

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 […]

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 […]

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 […]