Radiopharm Gets FDA Approval for RV-01 First-in-Human Cancer Trial

Radiopharm Theranostics (ASX: RAD) has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial of its novel therapeutic candidate Betabart (RV-01), a first-in-class Lu177-labeled B7-H3 monoclonal antibody.

Designed to selectively bind the 4Ig isoform of B7-H3, RV-01 targets an immune checkpoint molecule highly expressed in solid tumors and minimally present in healthy tissues. Preclinical studies have shown that RV-01 achieves hepatic clearance, allowing optimal tumor targeting with potentially reduced risk of hematological and renal toxicities—common challenges in radiopharmaceuticals with renal clearance pathways. Developed in collaboration with MD Anderson Cancer Center, RV-01 is Radiopharm’s first monoclonal antibody therapy to progress into clinical trials. Patient dosing in the first-in-human study is expected to begin in Q4 2025. The company believes RV-01’s unique targeting mechanism and safety profile position it as a promising candidate for patients with aggressive or treatment-resistant solid tumors, aiming to address significant unmet medical needs in oncology.

Customer Notice:

Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.

Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com