Rinzimetostat and Darolutamide: Himalayas-1 Phase 3 Clinical Trial

Himalayas‑1 is a newly initiated global Phase 3 registrational trial testing rinzimetostat (ORIC-944) in combination with darolutamide in men with metastatic castration‑resistant prostate cancer (mCRPC) who have previously been treated with abiraterone. The trial is designed as a pivotal study intended to support approval if the results are positive, with about 600 patients planned across […]

UPDATE: AO-252 Demonstrates 80% Clinical Benefit Rate as Development Shifts to Expansion Phase

AO-252, a first-in-class TACC3 inhibitor, continues to show early clinical promise in advanced solid tumours, with recent updates highlighting both improved efficacy through optimized dosing and a new formulation designed to enhance drug exposure. Interim data from an ongoing Phase 1/2 trial demonstrated a clear dosing-dependent effect. Transitioning from once-daily (QD) to twice-daily (BID) administration […]

Phase 3 Trial: Metformin in Men Receiving ADT for Prostate Cancer

Metformin may help blunt some of the harmful hormonal and metabolic changes caused by androgen deprivation therapy (ADT) in men with prostate cancer, according to a correlative analysis from the PRIME phase III randomized trial. ADT is a standard treatment for locally advanced and metastatic prostate cancer, but it is also associated with metabolic syndrome, […]

Soon to Start Phase 1/2 Trial: CRISPR-Edited Tregs Enter the Clinic for Solid Tumors

CRG-150, a CRISPR-edited regulatory T cell therapy has entered first-in-human testing for solid tumors, marking an unusual and potentially important step in oncology. The program is aimed at metastatic breast and prostate cancers, two settings where treatment options remain limited once disease becomes advanced. What makes this approach different is the cell type being used. […]

RIPCORD Phase 1 Trial: Interim PSMA PET–Guided Adaptive Radiotherapy in Metastatic Castration-Sensitive Prostate Cancer

RIPCORD is a UT Southwestern phase 1 trial testing a simple but important idea: can PSMA PET be used during treatment to decide how much metastasis-directed radiotherapy a patient actually needs? It focuses on men with poly-metastatic castration-sensitive prostate cancer and uses interim 68Ga-PSMA-11 PET to adapt stereotactic ablative radiotherapy (SABR) rather than giving every […]

Phase 1 Trial: 177Lu-PSMA-617 Plus Darolutamide in High-Risk Localized Prostate Cancer

A new trial phase 1 trial is investigating the combination of 177Lu-PSMA-617 (Pluvicto) with darolutamide in high-risk localized prostate cancer. Both agents are already established in prostate cancer care, but using them together before surgery is a novel way to intensify treatment in patients whose disease is still potentially curable. Its main idea is simple: […]

GRPR-Targeted Radioligand Therapy in Prostate Cancer: The A9-0631 and A9-0642 Trial

A new first-in-human study is testing whether GRPR-targeted radiopharmaceuticals can extend precision oncology beyond the PSMA and SSTR frameworks. The trial combines two therapeutic agents, 177Lu-A9-0631 and 225Ac-A9-0642, with GRPR imaging using 68Ga-A9-6217 or low-dose 177Lu-A9-0631 in patients with GRPR-positive solid tumors. GRPR, or gastrin-releasing peptide receptor, is an appealing target because it is overexpressed […]

ARTO Trial Final Results: Long-Term Survival Benefit of SBRT Added to Abiraterone in Oligometastatic mCRPC

The phase 2 ARTO trial findings, published on The Lancet, provides stronger evidence that metastasis-directed SBRT can improve outcomes in oligometastatic castration-resistant prostate cancer. In this randomized study, 157 patients were enrolled across 16 academic and community centers in Italy and assigned 1:1 to abiraterone plus ADT with or without SBRT to all visible metastatic […]

Bavdegalutamide Plus Abiraterone in Metastatic Prostate Cancer: Phase Ib Safety and Activity Results

Bavdegalutamide (ARV-110) is an oral androgen receptor degrader designed to address resistance to androgen-receptor–targeted therapy in metastatic prostate cancer. In this phase 1b study, it was combined with abiraterone in patients whose disease was progressing on abiraterone, with the goal of testing safety, pharmacokinetics, and early signs of antitumor activity. The trial enrolled 45 patients, […]

Another Phase 1/2 Trial With SX-682, Combined With Docetaxel This Time

SX-682 is moving into a new clinical context. After an ongoing trial in prostate cancer with androgen receptor pathway inhibitors such as apalutamide and enzalutamide, the CXCR1/2 inhibitor is now being studied with docetaxel in recurrent/metastatic head and neck squamous cell carcinoma, salivary gland carcinoma, and advanced prostate cancer. That matters because docetaxel is not […]