PDS01ADC is an investigational tumor-targeting IL-12 immunocytokine/ADC program developed for recurrent and metastatic cancers. It is administered by subcutaneous injection and is being studied in combination with Versamune-based immunotherapies. Current evidence places it in preclinical and clinical development rather than approved use.
PDS Biotechnology announced positive interim Phase 2 Stage 1 data for PDS01ADC plus HAIP in MSS/pMMR colorectal liver metastases. The trial showed a 77.8% objective response rate and about 85% 24-month survival in 9 patients.
PDS Biotechnology will report 2025 financial results and provide clinical updates on March 30, 2026. The company faces critical regulatory decisions for its Phase 3 VERSATILE-003 trial in HPV16-positive head and neck cancer and is expanding its immunotherapy platform to prostate cancer and other solid tumors.
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06096870 |
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy |
RECRUITING | PHASE2 |
| NCT05361798 |
A Phase II Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated With Androgen Deprivation Therapy |
RECRUITING | PHASE2 |
| NCT05286814 |
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma |
RECRUITING | PHASE2 |
| NCT04708470 |
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT04633252 |
A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer |
RECRUITING | PHASE1/PHASE2 |
| NCT04303117 |
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma |
RECRUITING | PHASE1/PHASE2 |
| NCT04235777 |
Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies |
RECRUITING | PHASE1 |
