Investigational Drug
PDS0301
TrialFetch AI Analysis
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Overview
PDS0301, also called PDS01ADC, M9241, or NHS-IL12, is an investigational cancer immunotherapy studied alone and in combinations. Human trial results are available, but its contribution to the effects of combination treatments remains uncertain. (pmc.ncbi.nlm.nih.gov)
Mechanism of action
PDS0301 joins two interleukin-12 (IL-12) molecules to the NHS76 antibody. The antibody binds exposed histone–DNA complexes in areas of tumor-cell death, with the aim of concentrating IL-12 where it can stimulate immune cells, including natural killer cells and T cells. (pmc.ncbi.nlm.nih.gov)
Efficacy
- Alone: In an initial phase 1 study, there were no objective tumor responses; 15 of 30 patients with measurable disease had stable disease. A separate 13-patient study of more frequent dosing also reported no complete or partial responses. (pmc.ncbi.nlm.nih.gov)
- With chemotherapy for colorectal liver metastases: A 2026 interim analysis reported responses at six months in 7 of 9 patients (78%) receiving PDS0301, hepatic-artery-infusion floxuridine, and systemic chemotherapy. Responses occurred in 7 of 20 (35%) patients in a separate, nonrandomized trial without PDS0301. The small groups and nonrandomized comparison cannot establish how much benefit PDS0301 added. (pmc.ncbi.nlm.nih.gov)
- With avelumab for urothelial cancer: The phase 1b expansion cohort recorded no objective responses among 16 patients and did not meet its prespecified criterion to continue. (pmc.ncbi.nlm.nih.gov)
Safety
In the colorectal combination study, 7 of 9 patients (78%) had grade 3 or higher adverse events; investigators attributed such an event to PDS0301 in 1 of 9. In the initial monotherapy study, commonly reported treatment-related effects included reduced lymphocyte counts, elevated liver enzymes, and flu-like symptoms. These findings do not yet define the safety of PDS0301 across treatment regimens. (pmc.ncbi.nlm.nih.gov)
Further reading
- 2026 phase 2 colorectal-cancer interim analysis (pmc.ncbi.nlm.nih.gov)
- Initial phase 1 monotherapy study (pmc.ncbi.nlm.nih.gov)
- Phase 1b study with avelumab (pmc.ncbi.nlm.nih.gov)
Last updated: Sep 2026
Active trials using PDS0301
Found 5 active trials using this drug:
TrialFetch AI summary: Adults with PSMA PET-positive prostate cancer recurring after surgery or radiation, a PSA doubling time under 12 months, and no disease detectable on conventional bone scan or CT/MRI receive a short course of enzalutamide without testosterone-lowering therapy, with or without PDS01ADC. PDS01ADC is an investigational immunocytokine that targets exposed histone–DNA complexes in necrotic tumor tissue to deliver interleukin-12 and stimulate immune cells.
ClinicalTrials.gov ID: NCT06096870
TrialFetch AI summary: Adults with unresectable, liver-dominant colorectal metastases, intrahepatic cholangiocarcinoma, or metastatic adrenocortical carcinoma after at least one prior systemic chemotherapy regimen receive hepatic artery infusion of floxuridine plus dexamethasone and disease-appropriate systemic chemotherapy. They also receive PDS01ADC, an investigational antibody–IL-12 fusion designed to bind exposed DNA in necrotic tumor tissue and stimulate local antitumor immunity.
ClinicalTrials.gov ID: NCT05286814
TrialFetch AI summary: Men with metastatic castration-sensitive prostate cancer starting ADT receive M9241 plus docetaxel, abiraterone, and prednisone; men with metastatic castration-resistant disease previously treated with ADT and a modern antiandrogen, but not docetaxel for mCRPC, receive M9241 plus docetaxel and prednisone. M9241 is an investigational IL-12 immunocytokine designed to bind tumor-associated histone–DNA complexes and stimulate antitumor immune activity.
ClinicalTrials.gov ID: NCT04633252
TrialFetch AI summary: Adults with progressing metastatic non-prostate genitourinary cancer, including urothelial or renal cell cancer, receive bintrafusp alfa (PD-L1 blockade and TGF-β trapping) plus PDS01ADC (tumor DNA-targeted IL-12), either alone or with sequential or concurrent SBRT. Prior checkpoint inhibition is permitted; radiation arms require an irradiable lesion.
ClinicalTrials.gov ID: NCT04235777
TrialFetch AI summary: Adults with advanced, biopsy-confirmed Kaposi sarcoma requiring systemic therapy, including eligible patients with controlled HIV, receive NHS-IL12 (PDS01ADC) alone or with bintrafusp alfa. NHS-IL12 targets exposed tumor DNA to deliver IL-12–mediated immune stimulation; bintrafusp alfa blocks PD-L1 and traps TGF-β.
ClinicalTrials.gov ID: NCT04303117
