On August 25, 2021 XRad Therapeutics reported that first patient dosed in Phase 1a Clinical Trial of XRD-0394 for metastatic, locally advanced or recurrent solid tumours(Press release, Aptus Clinical, AUG 25, 2021, View Source [SID1234586867])
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Aptus Clinical is providing CRO support for this study
The dosing of the first patient into US based XRad Therapeutics’ Phase 1a study of XRD-0394 in metastatic, locally advanced or recurrent solid tumours, marks a major milestone for XRad and Aptus Clinical. For XRad, XRD-0394 is their first asset to reach clinical development, whilst for Aptus this is the first study utilising their US-based CRA team. As part of Aptus’ full-service delivery capability, the US CRAs, working alongside their UK headquartered clinical operations and data management colleagues, now provide significant geographical extension to Aptus’ current experience delivering early phase oncology, cell & gene therapy and rare disease clinical trials in in the UK and EU.
This Phase 1a trial will evaluate the safety and tolerability of single ascending doses of XRD-0394 in combination with radiation therapy. The trial is being conducted at two world renowned centres of excellence: Memorial Sloan Kettering Cancer Center in New York and the Stanford Cancer Institute in Palo Alto, California. XRD-0394 is a first-in-class, oral, dual kinase inhibitor of both ataxia-telangiectasia mutated and DNA-dependent protein kinase and based on preclinical studies is designed to enhance the effectiveness of radiation therapies. Results from this trial will inform the dosing regimen for the company’s planned Phase 1b study.
Tona Gilmer, PhD, President, Chief Executive Officer and co-founder of XRad said in a statement: "We are delighted to be working with our clinical CRO partners at Aptus who are managing the delivery of this vital first study in our development programme. Successful completion will allow us to rapidly move to the next step in our clinical development"
Jonathan Lewis, co-founder and Chief Commercial Officer at Aptus Clinical commented "We are thrilled that the XRad team entrusted the clinical delivery of their first asset to Aptus. Having worked initially with members of our consulting team, recognition of the strength and depth of experience in our operational delivery organisation has been a great endorsement of our capabilities. We look forward to working alongside the XRad team to demonstrate the full benefits of this important potential addition to the cancer treatment armamentarium"