Drugs / HAFNIUM OXIDE
HAFNIUM OXIDE
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04615013 | Nov 2020 → Oct 2027 expected | esophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT03589339 | Jan 2019 → Apr 2027 expected | head and neck squamous cell carcinoma, high grade malignant neoplasm, metastatic melanoma, non-small cell lung carcinoma +5 | Nanobiotix | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07224152 | Mar 2026 → Aug 2028 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02805894 | Nov 2017 → Mar 2020 | prostate cancer | Nanobiotix | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Nanobiotix | Results NANOBIOTIX Announces Complete Full Cohort Phase 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent Non-Small Cell Lung Cancer nanobiotix.com ↗
One-year locoregional control rate was 79%, one-year local progression-free survival (LPFS) was 61%, and one-year overall survival (OS) was 70% in evaluable subjects— achieved at a lower re-irradiation dose than patients’ prior course of radiotherapy |
| 2026-05-17 | Nanobiotix | Results Nanobiotix Announces Presentation of Part 1 Data From a Randomized Phase 2 Clinical Trial Evaluating JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer nanobiotix.com ↗
Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC |
| 2026-05-04 | Nanobiotix | Regulatory Nanobiotix Announces Protocol Amendment to Ongoing Global Phase 3 Head and Neck Cancer Study nanobiotix.com ↗
today announced FDA acceptance of a protocol amendment to the ongoing pivotal NANORAY-312 study. |
| 2026-03-30 | Nanobiotix | Results NANOBIOTIX Announces Presentation of First Data from a Randomized Phase 2 Clinical Trial Evaluating JNJ-1900 (NBTXR3) in Stage 3 Inoperable Lung Cancer nanobiotix.com ↗
Initial efficacy responses observed in 7 patients at first disease evaluation following concurrent chemoradiotherapy, and before treatment with anti-PD-L1, are promising (ORR = 71.4%; DCR = 100%) relative to the estimated benchmark (ORR = 45%-50%). |
| 2025-10-01 | Nanobiotix | Results NANOBIOTIX Announces First Data From Phase 1 Study Evaluating JNJ-1900 (NBTXR3) for Patients With Esophageal Cancer nanobiotix.com ↗
Treatment was well-tolerated and injection feasibility was confirmed in 13 patients with locally advanced adenocarcinoma of the esophagus 85% (11/13) disease control rate (DCR) 69% (9/13) objective response rate (ORR); 6 complete responses and 3 partial responses |
| 2025-09-29 | Nanobiotix | Results NANOBIOTIX Announces Updated Phase 1 Results Continuing to Support JNJ-1900 (NBTXR3) Plus Anti-PD-1 as a Potential New 1L or 2L+ Option in Anti-PD-1 Naïve or Resistant R/M-HNSCC nanobiotix.com ↗
63% (26/41) disease control rate (“DCR”) and 37% (15/41) objective response rate (“ORR”) in evaluable anti-PD-1 naïve patients per RECIST 1.1 |
| 2025-09-17 | Nanobiotix | Results NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1 nanobiotix.com ↗ |
| 2025-07-07 | Nanobiotix | Regulatory NANOBIOTIX Announces Regulatory Harmonization and New Composition of Matter Patent Filed for JNJ-1900 (NBTXR3) nanobiotix.com ↗
Health authorities in major European countries have accepted the reclassification of JNJ-1900 (NBTXR3) from a medical device to a medicinal product, aligning with regulatory status in the US and other major markets |
| 2025-05-05 | Nanobiotix | Results Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer nanobiotix.com ↗
today announced the presentation of full results from the completed dose escalation and dose expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer. |
| 2025-03-27 | Nanobiotix | Results Nanobiotix Announces First Data From the Completed Dose Escalation Part of a Phase 1 Study Evaluating NBTXR3 (JNJ-1900) as a 2L+ Therapy for Patients With Locally Advanced NSCLC nanobiotix.com ↗
Data show favorable safety and confirm injection feasibility in 12 patients with locally advanced NSCLC amenable to re-irradiation for whom prior lines of therapy have failed |
| 2024-12-09 | Nanobiotix | Results NANOBIOTIX Announces Completion of Phase 1 Study of NBTXR3 (JNJ-1900) in Pancreatic Cancer nanobiotix.com ↗
Investigators concluded that the encouraging oncologic outcomes coupled with a favorable safety profile warrant further evaluation in a randomized trial |
| 2024-06-02 | Nanobiotix | Results Nanobiotix Announces New Data Showing Disease Control and Tumor Response in Patients Treated With RT-Activated NBTXR3 Followed By anti-PD-1 For 2l+ R/M HNSCC Naïve or Resistant to Prior anti-PD-1 Therapy nanobiotix.com ↗
Data show favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; “ITT”) who received RT-activated NBTXR3 followed by anti-PD-1 as a second-or-later line treatment |
| 2024-05-28 | Nanobiotix | Results NANOBIOTIX Announces Presentation of new Data From Phase 1 Immunotherapy Program at the 2024 Annual Meeting of the American Society for Clinical Oncology Followed by an Investor Conference Call nanobiotix.com ↗
Early signs of efficacy in patients with anti-PD-1 naïve (n=33) and anti-PD-1 resistant (n=35) HNSCC treated with NBTXR3/SBRT in combination with nivolumab and pembrolizumab in the phase 1 trial Study 1100 |
| 2024-05-14 | Nanobiotix | Regulatory NANOBIOTIX Announces US FDA Protocol Acceptance for New Randomized Phase 2 Study Evaluating NBTXR3 for Patients with Stage Three Lung Cancer nanobiotix.com ↗
today announced that the U.S. Food and Drug Administration (“US FDA”) issued a Study May Proceed Letter for a randomized Phase 2 study evaluating NBTXR3 for the treatment of patients with stage 3, unresectable non-small cell lung cancer (“NSCLC”). |
| 2024-04-02 | Nanobiotix | Results Nanobiotix Announces Completion of Phase 1 Dose Escalation and NBTXR3 Recommended Phase 2 Dose for the Treatment of Inoperable, Recurrent Lung Cancer in Patients Amenable to Re-Irradiation nanobiotix.com ↗ |
| 2023-10-23 | Nanobiotix | Results NANOBIOTIX Announces Updated Preliminary Results From Phase 1 Pancreatic Cancer Trial and New Exploratory Analysis From Completed Phase 1 Head and Neck Cancer Trial at ESMO 2023 nanobiotix.com ↗
These data suggest that the high rate of Objective Response to RT-activated NBTXR3 could potentially extend PFS and OS for elderly, frail patients with locally advanced head and neck cancer |
| 2023-10-04 | Nanobiotix | Results Nanobiotix Announces the Presentation of the Final Efficacy Analysis From Phase 1 Cohort Expansion Evaluating NBTXR3 in Locally Advanced Head and Neck Cancer Showing Median Progression-Free Survival of 16.9 Months and Median Overall Survival of 23.1 Month nanobiotix.com ↗
Median Progression Free of 16.9 months in the evaluable population per independent review committee at the final readout |
| 2023-09-28 | Nanobiotix | Results NANOBIOTIX Announces Presentation of First Data From Phase 1 Study Evaluating NBTXR3 for Patients With Locally Advanced Pancreatic Cancer nanobiotix.com ↗
Preliminary data show local endoscopic injection of NBTXR3 followed by radiotherapy activation remains feasible with a tolerable safety profile in 15 patients |
| 2022-11-14 | Nanobiotix | Results NANOBIOTIX Announces Recommended Phase 2 Dose for NBTXR3 in Pancreatic Cancer nanobiotix.com ↗
The recommended phase 2 dose for radiotherapy-activated NBTXR3 in pancreatic cancer was established at 42% of gross tumor volume and the dose expansion part of the study is ongoing in the United States |
| 2022-11-10 | Nanobiotix | Results NANOBIOTIX Reports Updated Phase 1 Anti-PD-1 Combination Data That May Support the Immune Stimulation Potential of Radioenhancer NBTXR3 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer nanobiotix.com ↗
Objective reduction from baseline in all target lesions (“objective reduction”) was observed in 71.43% of evaluable patients (15/21) and objective reduction of more than 30% was observed in 42.86% of evaluable patients (9/21) |
| 2022-09-21 | Nanobiotix | Results Nanobiotix Establishes Recommended Dose for Planned Registrational Study Evaluating NBTXR3 Plus Anti-PD-1 for Patients With Metastatic Head and Neck Cancer Resistant to Prior Immunotherapy nanobiotix.com ↗
RP2Ds were determined for NBTXR3 plus pembrolizumab or nivolumab for patients with LRR or R/M HNSCC that has not received prior immunotherapy, lung metastases (mets) from any primary tumor, or liver mets from any primary tumor as well. |
| 2022-06-05 | Nanobiotix | Results NANOBIOTIX: New Data Featuring NBTXR3 Plus Chemoradiation and in the Preoperative Setting Support Broad Applicability for Head and Neck Cancer and Other Solid Tumor Indications nanobiotix.com ↗ |
| 2022-04-11 | Nanobiotix | Results NANOBIOTIX: New Preclinical Immunotherapy Data Show Boosted Anti-Tumor Immune Activation via Triple Blockade of PD-1, LAG-3, and TIGIT When Combined With Radiotherapy-Activated NBTXR3 nanobiotix.com ↗ |
| 2022-03-30 | Nanobiotix | Results NANOBIOTIX Provides Business Update and Reports Full Year 2021 Financial Results nanobiotix.com ↗
New data from Expansion Study 102 in high-risk, LA-HNSCC patients highlights potential clinical benefit of NBTXR3 showing a median Overall Survival reaching 23 months in evaluable patients; Data with minimum follow-up of one year for full study population anticipated in mid-2023 |
| 2022-02-09 | Nanobiotix | Results Nanobiotix Announces Publication of New Clinical Case Study Highlighting First Patient Experience of NBTXR3 Treatment for Pancreatic Cancer nanobiotix.com ↗
Peer-reviewed clinical case study reported preliminary data on the first-in-human administration of NBTXR3 for the treatment of pancreatic cancer not eligible for surgery, demonstrating feasibility with no treatment-related toxicity |
| 2022-01-26 | Nanobiotix | Results NANOBIOTIX Announces Publication of New Preclinical Immunotherapy Data Showcasing the Combination Potential of NBTXR3 With anti-PD-1 and anti-CTLA-4 nanobiotix.com ↗
Data suggest that the potential immune priming effect of NBTXR3 may scale beyond anti-PD-1, and could merit further investigation in preclinical and clinical settings |
| 2022-01-05 | Nanobiotix | Results Preclinical data presented at AACR virtual special conference showed NBTXR3 combo overcomes anti-PD-1 resistance, promotes strong abscopal effect and long-term anti-cancer memory nanobiotix.com ↗ |
| 2022-01-05 | Nanobiotix | Results Nanobiotix Reports New Data for Potential First-In-Class Radioenhancer NBTXR3 in Combination with Anti-Pd-1 Showing Local or Distant Tumor Regression in 76.9% of Evaluable Patients Regardless of Prior Anti-Pd-1 Exposure nanobiotix.com ↗
Objective response was observed in 60% of anti-PD-1 naïve patients and 50% of prior non-responders |
| 2022-01-05 | Nanobiotix | Results Nanobiotix Announces Updated Results From Priority Pathways In Head And Neck Cancer And Immunotherapy For Potential First-In-Class Radioenhancer NBTXR3 At 2021 Annual Meeting Of The American Society For Clinical Oncology nanobiotix.com ↗
Updated results from phase I dose expansion in head and neck cancer showed durable signs of efficacy at a median follow up of 8.1 months, with an overall objective response rate of 82.5% and a complete response rate of 62.5% [1] |
| 2022-01-05 | Nanobiotix | Results Nanobiotix announces Red Journal publication of preclinical data showing radioenhancer NBTXR3 may “reprogram” the tumor microenvironment to overcome anti-PD-1 resistance and evoke abscopal effect nanobiotix.com ↗
Data supported the hypothesis that the triple combination could effectively control primary and metastatic tumors, evoke abscopal effect, and reduce the possibility of developing distant lung metastases |
| 2022-01-05 | Nanobiotix | Results Nanobiotix announces positive first results for novel NBTXR3 in rectal cancer study at ASCO-GI 2021 nanobiotix.com ↗
More than 70% of patients showed objective tumor response after concurrent chemoradiation |
| 2022-01-05 | Nanobiotix | Results Nanobiotix Announces New Preclinical Data Highlighting NBTXR3 Immune Priming and Checkpoint Inhibitor Combination nanobiotix.com ↗
Data show radiotherapy-activated NBTXR3 increased CD8+ T cell infiltration and modulated the T cell receptor repertoire in a mouse model, suggesting stronger immune priming triggered by the therapy compared to radiotherapy alone |
| 2022-01-05 | Nanobiotix | Results Nanobiotix announces 18.1 month median overall survival for 41 evaluable elderly and frail patients with HNSCC in phase I expansion evaluating NBTXR3 as a single agent activated by radiotherapy nanobiotix.com ↗ |
| 2021-01-05 | PharmaEngine | Results PharmaEngine, Inc. Announces First Results for PEP503(NBTXR3) in Rectal Cancer Study at ASCO-GI 2021 pharmaengine.com ↗
More than 70% of patients in the study showed objective tumor response after CCRT. |
All press releases naming this drug 57 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HAFNIUM OXIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298051 ↗ |
| Known as | NBTXR3 | “hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3)” NCT04615013 ↗ |
| Known as | NSC-158931 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298051 ↗ |
| Modality | Other / unclassified | “Hafnium Oxide nanoparticles” NCT02805894 ↗ |
| Route | Other | “Single local administration of NBTXR3 by injection into the prostate gland” NCT02805894 ↗ |