Avacta Group (AIM: AVCT) has presented the trial design for its pancreatic cancer drug AVA6103, a peptide-drug conjugate targeting pancreatic ductal adenocarcinoma. The company detailed the FOCUS-01 Phase 1 study design at the American Association for Cancer Research Conference on Pancreatic Cancer in San Diego.
The FOCUS-01 Phase 1 study covers preclinical data and features a dose-dense arm with dosing every two weeks, compared to the traditional three-week dosing schedule for antibody-drug conjugates. The FOCUS-01 Phase 1a trial is actively enrolling patients with select tumor types predicted to be sensitive to exatecan, including pancreatic ductal adenocarcinoma, which are enrolled in the two-week dosing arm.
Preclinical findings from patient-derived xenograft mouse models showed tumor-targeted delivery of exatecan, resulting in complete and partial responses in multiple models that persisted for weeks after dosing stopped. Researchers noted high fibroblast activation protein (FAP) expression in pancreatic ductal adenocarcinoma, alongside close proximity of FAP-expressing cancer-associated fibroblasts to blood vessels and tumor cells.
Preliminary safety and pharmacokinetic data from the first three dose levels showed that AVA6103 was well tolerated up to a payload dose approximately 50% higher than the maximum tolerated dose of conventional exatecan. Enrollment is ongoing in both study arms, with patients currently being treated at dose level 4. Avacta expects an initial efficacy readout from the study in the first half of 2027.
