Radiopharm Theranostics (ASX: RAD) has dosed the first patient in its first-in-human (FIH) Phase 1/2a clinical trial of 177Lu-Betabart (RV-01) to treat aggressive cancers.
The trial will evaluate the therapeutic drug’s preliminary anti-tumour activity, along with its safety profile, biodistribution, pharmacokinetics, and radiation dosimetry to determine a recommended dose of RV-01 for future studies.
It aims to enrol 61 participants with a documented history of histopathologically-confirmed and castrate-resistant variants.
These include prostate, colorectal, small cell and non-small cell lung, head and neck squamous cell, ovarian, cervical, endometrial, triple negative breast, and esophageal squamous cell cancers.
Cancer Immunotherapy Target
Radiopharm Ventures (a joint venture between Radiopharm and The University of Texas MD Anderson Cancer Centre) developed RV-01 as an Lu177-tagged engineered monoclonal antibody with a strong affinity for the 4Ig isoform of B7-H3.
B7-H3 is an immune checkpoint molecule which is overexpressed across several tumour types and has emerged as a compelling target for antibody-based cancer immunotherapy.
Deregulated B7-H3 expression is consistently correlated with enhanced tumour aggressiveness and poor clinical outcomes.
In July, Radiopharm received investigational new drug clearance from the US Food and Drug Administration for RV-01, allowing it to initiate the FIH Phase 1/2a clinical trial.
Highly Differentiated Option
Radiopharm chief executive officer Riccardo Canevari said dosing of the first patient marked an important milestone for the company.
“This is the first radiotherapeutic agent from our joint venture to enter the clinic, and we believe it has the potential to become a highly differentiated option for patients with aggressive advanced solid tumours,” he said.
Preclinical studies have shown evidence of RV-01’s efficacy and targeting of the 4Ig isoform of B7-H3 such as tumour shrinkage and prolonged survival in animals treated with the radiotherapeutic agent.
The findings support the drug’s potential use in multiple indications including prostate, pancreatic and breast cancers and other solid tumours.
