Biopharmaceutical company Avacta Group plc (AIM:AVCT) reported on Monday that it has opened a Phase 1 clinical trial for FAP-Exd (AVA6103), its second pipeline programme and the first sustained-release pre|CISION peptide drug conjugate developed using the company's tumour-activated oncology delivery platform.

The Phase 1a dose-escalation study will assess safety, tumour and plasma pharmacokinetics, and preliminary efficacy of AVA6103 in patients with advanced solid tumours, including pancreatic cancer, cervical and vulvar cancer, gastric and gastroesophageal junction cancers, and small cell lung cancer. The trial is designed to determine a dose and treatment regimen for further clinical development.

Avacta Group expects to enrol the first patient before the end of March. The study will evaluate two dosing schedules, administered every two weeks and every three weeks, with preliminary safety and pharmacokinetic data anticipated in the second half of 2026.

Initial recruitment will take place at the Virginia Cancer Specialists Research Institute in Fairfax, Virginia, and NEXT Oncology Specialists in Dallas, Texas.

AVA6103 is a fibroblast activation protein-released version of exatecan, a potent topoisomerase I inhibitor. The therapy uses Avacta Group's proprietary pre|CISION platform, designed to release cancer therapies within the tumour microenvironment by targeting fibroblast activation protein, reducing systemic exposure and associated toxicity.