other_material
confidence high
sentiment positive
materiality 0.55
PDS Biotech colorectal cancer cohort in NCI-led Phase 2 trial of PDS01ADC meets criteria for Stage 2 expansion
PDS Biotechnology Corp
- Stage 1 of NCI-led Phase 2 trial for PDS01ADC + FUDR/HAIP in metastatic colorectal cancer met RECIST v1.1 criteria for expansion.
- 6 of 9 patients achieved objective response in Stage 1, triggering Simon two-stage design expansion to up to 22 patients.
- Enrollment in Stage 2 for colorectal cancer cohort underway; completion targeted by Q4 2025.
- Two other cohorts (cholangiocarcinoma, adrenocortical cancer) continue enrolling in Stage 1.
item 8.01item 9.01