Phase 1 Trial: GTB-5550, Another B7-H3 NK-targeted Therapy for mCRPC

GTB-5550 has begun Phase 1 clinical testing in solid tumors, marking the first patient dosing in a dose-escalation basket study. The trial is starting with prostate cancer, a setting where B7-H3 is reportedly highly expressed and where treatment options remain limited in the metastatic castration-resistant stage. The therapy is being delivered subcutaneously, which is notable […]

Phase 1 Trial: INR731 for mCRPC

INR731 is an oral, investigational anticancer drug now entering first‑in‑human testing for men with metastatic castration‑resistant prostate cancer (mCRPC). It is being evaluated in a global, open‑label Phase 1 study with the primary goal of defining its safety, tolerability, pharmacokinetics, pharmacodynamics, and a recommended dose for further development, rather than demonstrating efficacy at this stage. […]

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 […]