Phase 1/2 Trial Results for Tinengotinib (TT-00420) in mCRPC

Tinengotinib (TT-00420), a multikinase inhibitor with a distinctive target profile, is showing early signals in metastatic castration‑resistant prostate cancer (mCRPC), a setting where options after modern androgen‑receptor pathway inhibitors and taxanes remain limited. Results from a US‑based, multicenter phase 1/2 trial, published in Clinical Cancer Research, reported an objective response rate of 33.3% in a […]

UPDATE: MRT-2359 Plus Apalutamide Combination Enters Phase 2 Trial for AR-Mutated Advanced Prostate Cancer

A new phase 2 trial is evaluating MRT-2359 in combination with apalutamide for patients with androgen receptor (AR) mutation-positive metastatic castration-resistant prostate cancer, an advanced disease that may become resistant to standard hormone-directed treatments. The first patient has been dosed in the MODeFIRe-1 study, which plans to enroll up to 25 patients. Participants must have […]

Phase 1/2 Trial for CRG-150, a New Approach to Immunotherapy

CRG-150 is entering first-in-human testing as an unconventional immunotherapy for patients with relapsed or refra9ctory metastatic prostate cancer and other solid tumors. The autologous, CRISPR-edited cell therapy targets steroid receptor coactivator 3, or SRC-3, in regulatory T cells. Tregs help maintain immune tolerance but can suppress antitumor immunity in prostate cancer. By disrupting SRC-3, CRG-150 […]

Soon to Be Phase 1/2 Trial: Bria-PROS+ Receives FDA Clearance to Begin Clinical Study in Prostate Cancer

Bria-PROS+ has received clearance from the U.S. Food and Drug Administration to enter clinical testing as an investigational personalized, off-the-shelf cellular immunotherapy for prostate cancer. The FDA completed its review of the Investigational New Drug application allowing a Phase 1/2a clinical study to move forward. The study is expected to evaluate the safety, tolerability, and […]

UPDATE: Seven Complete Responses in a 19-Patient Cohort of 67Cu-SAR-bisPSMA Trial for mCRPC

A small but encouraging clinical dataset suggests that 67Cu-SAR-bisPSMA may produce substantial anti-tumour activity in patients with metastatic castration-resistant prostate cancer (mCRPC) who have exhausted multiple treatment options. The findings come from the SECuRE clinical trial, in which 19 participants received treatment with 67Cu-SAR-bisPSMA at an 8 GBq dose. Despite the advanced disease setting, treatment […]

Phase 2 Trial for Xaluritamig in Patients With mCRPC and Suboptimal Response to Pluvicto

Thomas Jefferson University is running a phase 2 study of xaluritamig, also known as AMG 509, in adults with metastatic castration-resistant prostate cancer whose disease has shown a suboptimal response to Lu-177 vipivotide tetraxetan (aka 177Lu-PSMA 617) the radioligand therapy better known as Pluvicto. The trial reflects a very specific and clinically important question: what […]

UPDATE: SL-28 Phase 1/2 Trial Started To Recruit in Advanced Solid Tumors

A very interesting Phase 1/2 trial of SL‑28 has started enrolling up to 60 patients with advanced solid tumours at The Southern Oncology Clinical Research Unit (SOCRU). Although the study is open to a broad range of solid cancers, it is particularly noteworthy for prostate cancer because a published case report described a complete response […]

Phase 2 Trial: Adaptive PSMA-PET–Guided 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in mHSPC

The OPTIMAL-e trial is a phase 2 pilot study testing adaptive, PSMA-PET–guided radioligand therapy (RLT) with 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in men with metastatic hormone-sensitive prostate cancer (mHSPC), on top of standard androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI). Conducted at St Vincent’s Hospital in Sydney, it is single-arm, open-label, and nonrandomized, designed […]

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 […]

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. […]