Drugs / PDS01ADC
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04235777 | Jul 2020 → Aug 2026 overdue | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT04708470 | Oct 2021 → May 2025 | anus cancer, cervical cancer, human papilloma virus infection, oropharynx cancer +3 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT04633252 | Feb 2021 → Dec 2026 expected | prostate cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04303117 | Jul 2020 → Dec 2028 expected | Kaposi's sarcoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06096870 | Apr 2024 → Dec 2028 expected | prostate carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05361798 | Jun 2023 → Aug 2027 expected | prostate cancer | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05286814 | Oct 2022 → Dec 2027 expected | adrenal cortex carcinoma, colorectal cancer, intrahepatic cholangiocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-08-13 | PDS Biotechnology Corp. | Results PDS Biotech Reports Second Quarter 2026 Financial Results pdsbiotech.com ↗
Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS0301, the ORR was 35% (7/20) |
| 2026-04-15 | PDS Biotechnology Corp. | Results PDS Biotech Announces Publication of Positive PDS01ADC Interim Phase 2 Clinical Trial Data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) Trial pdsbiotech.com ↗
today announced the publication of clinical and immunological biomarker data from Stage 1 of a Phase 2 trial evaluating its tumor-targeted IL-12 immunocytokine, PDS01ADC, in the March 10, 2026 issue of Journal of Clinical Oncology (JCO) Oncology Advances. |
| 2026-01-30 | PDS Biotechnology Corp. | Results PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI pdsbiotech.com ↗
Results showed median progression-free survival (“PFS”) of 9.6 months (range: 4.3–32.2 months) for the combination therapy in mCRPC patients. |
| 2025-11-13 | PDS Biotechnology Corp. | Results PDS Biotech Reports Third Quarter 2025 Financial Results and Provides Clinical Programs Update pdsbiotech.com ↗
Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results |
| 2025-11-10 | PDS Biotechnology Corp. | Results PDS Biotechnology Announces Translational Data Showing Strong Immunological and Clinical Activity of PDS0101 and PDS01ADC Presented at SITC 2025 pdsbiotech.com ↗
PDS01ADC monotherapy promoted generation of multi-functional NK cells that were associated with induction of a clinical response in advanced treatment-resistant patients with solid tumors. |
| 2025-08-13 | PDS Biotechnology Corp. | Results PDS Biotech Reports Second Quarter 2025 Financial Results and Provides Clinical Programs Update pdsbiotech.com ↗
Metastatic colorectal cancer cohort in study led by the National Cancer Institute demonstrated promising response rate (≥6 of 9 confirmed objective responses by RECIST v1.1), triggering enrollment expansion under Simon Two-Stage design |
| 2025-07-10 | PDS Biotechnology Corp. | Results PDS Biotech Announces Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results pdsbiotech.com ↗
This milestone has been achieved for the colorectal cancer cohort, and enrollment has progressed to Stage 2. |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PDS01ADC | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04633252 ↗ |
| Known as | NHS-IL12 | “PDS01ADC (previously referred to as NHS-IL12) is a novel antibody-drug conjugate designed to deliver the immunomodulatory cytokine interleukin-12 to areas of tumor necrosis and...” PMID 42365236 ↗ Jun 20261“PDS01ADC (NHS-IL12) is an immunocytokine composed of two IL-12 heterodimers, each fused to the H-chain of the NHS76 antibody.” NCT05361798 ↗ |
| Modality | Protein / enzyme biologic | “PDS01ADC is an immunocytokine composed of two interleukin (IL)-12 heterodimers, each fused to the H-chain of the NHS76 antibody.” NCT04235777 ↗ |
| Route | Subcutaneous | “An initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks while on M7824 and with or without SBRT” NCT04235777 ↗ |