Radiopharm Theranostics (ASX:RAD) said the first patient was dosed in its first-in-human phase 1/2a dose escalation and expansion clinical trial of lutetium-177-Betabart drug candidate, or RV-01, for the potential treatment of several types of tumors, according to a Tuesday Australian bourse filing.
The study is designed to evaluate the safety, biodistribution, and radiation dosimetry of RV-01, as well as its preliminary anti-tumor activity, the filing said. The US Food and Drug Administration previously provided an investigational new drug clearance for RV-01. It targets B7-H3, an immune checkpoint molecule that is over-expressed in several tumor types.
The study plans to enroll 61 eligible participants with a documented history of histopathologically confirmed castrate-resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma.
The company's shares rose nearly 5% in recent trading on Tuesday.