Rencarex (girentuximab)

P1, N=24, Not yet recruiting, Institut Cancerologie de l'Ouest

[89Zr]Zr-girentuximab PET/CT is a sensitive imaging method and offers promise for novel theranostics for mTNBC patients.

A recent phase III trial (ZIRCON) is widely believed to have laid the groundwork for United States Food and Drug Administration approval of the CAIX monoclonal antibody 89Zr-girentuximab...Further, emerging new targeted radiotracers and techniques such as imaging biomarker discovery with artificial intelligence will bolster those concepts. In this manual, we synthesize key data into a recommended approach.

P1/2, N=100, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Oct 2025 --> Oct 2027

The use of SLNB has transformed nodal staging in PeC, influencing treatment decisions and reducing morbidity in patients undergoing surgery. In other urological malignancies, it has not yet established itself as a standard tool for nodal staging. Its impact on survival, quality of life, and translational research remains to be determined.

P=N/A, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Apr 2026

The aim is to activate cGAS-STING-induced antitumor immunity via targeted radioimmunotherapy damage to DNA. If successful, this approach could establish a novel paradigm that combines radiopharmaceuticals with immunotherapy and targeted therapy in ccRCC.

Preclinical and clinical data demonstrate the promising therapeutic role of 211At-targeted alpha agents in NMIBC, and the [211At]At-anti-CA-IX antibody (ATO-101™) could fulfill this role. A phase I FIH clinical trial is in preparation, and results are expected within the next years.

New approaches based on small molecule inhibitors and monoclonal antibodies such as girentuximab provided encouraging results in preclinical research and clinical trials. These advances highlight the potential of hCA-targeted therapies to improve cancer treatment for hypoxic tumors.

177Lu-DOTA-girentuximab (targeting carbonic anhydrase IX) or 177Lu-DOTA-rosopatamab (targeting prostate-specific membrane antigen) was used to deliver β-radiation to tumors via a single intravenous dose (3 or 6 MBq) in mice bearing SK-RC-52 RCC or LNCaP prostate cancer xenografts, respectively. Our findings suggest a synergistic effect between peposertib and 177Lu-based radioimmunotherapy, wherein peposertib enhanced the efficacy of radioimmunotherapy. This synergy indicates the potential to reduce the necessary dose of radioimmunotherapy for effective cancer treatment.

P1/2, N=100, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting

[89Zr]ZrDFOSq-girentuximab has high uptake in CAIX positive tumours. An automated procedure for the synthesis of [89Zr]ZrDFOSq-girentuximab using [89Zr]ZrCl4 as a starting material has been developed. This automated process could be readily adapted to other antibodies.