Radiopharm reports positive Phase 1 imaging data for RAD301 in pancreatic cancer

Radiopharm Theranostics announced on September 8, 2026 (with the related 6-K dated September 9, 2026) positive results from a Phase 1 imaging trial evaluating RAD301 for safety, biodistribution and dosimetry in healthy volunteers and subjects with Pancreatic Ductal Adenocarcinoma.¹

RAD301 is described as a peptide-based molecule bound to Gallium-68 that targets αvβ6-integrin, a marker linked to tumor invasion and metastatic growth whose expression correlates with worse survival in several carcinomas.¹ The company noted that this integrin receptor appears in high density on most pancreatic carcinoma cells, making it a potential diagnostic and therapeutic target.¹ RAD301 previously received Orphan Drug Designation from the FDA.¹

According to the release, the trial showed a favorable safety profile across all evaluable participants.¹ The company said imaging results were consistent with an earlier interim look, reporting good biodistribution and strong tumor uptake in pancreatic cancer metastases that matched what had been seen in the first five patients studied. Radiopharm added that tumor uptake was described as significant and selective, which it said supports further investigation of αvβ6-integrin as a target for treatment and possibly for pairing diagnostic and therapeutic uses. The company also pointed to low signal in the liver, lung, and bowel, common sites of pancreatic cancer spread, saying this could help RAD301 tell metastatic tumor tissue apart from healthy tissue.

Radiopharm said the combination of high unmet need in earlier-stage disease and the disease's high mortality supports moving forward with a planned Phase 2 imaging trial of RAD301. The company's broader pipeline currently includes one Phase 2 and five Phase 1 trials across solid tumors such as lung, breast, prostate and brain.¹