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Clinical trials
catalyst calendar across sponsors →Studies where IMNN is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
15 interventional · 3 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal CancerNCT06915025Overall SurvivalRandomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer), Paclitaxel, Carboplatin, Olaparib, Niraparib | Epithelial Ovarian Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma | 500 | 2032-10-31 | in 2,265 d | 2026-08-04 |
| Phase II IMNN-001 (Also Known as GEN-1) on SLL With BEV and NACT, Newly Diagnosed Advanced Ovarian, Fallopian Tube or Primary Peritoneal CancerNCT05739981Minimal Residual DiseaseRandomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Paclitaxel, Carboplatin, Bevacizumab, IMNN-001 | Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer | 30 | 2027-06-30 | in 315 d | 2026-08-04 |
| Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)NCT03393884PFSRandomized · Open-label · Treatment | Phase 1/2 | Active, not recruiting | Biological: IMNN-001 · Drug: Carboplatin, Paclitaxel | Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer | 130 | 2024-07-25actual | — | 2026-05-04 |
| Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2NCT06283459Number of participants with local and systemic reactogenicity adverse events and all adverse eventsOpen-label · Prevention | Phase 1/2 | Completed | Biological: IMNN-101 | SARS CoV 2 Infection | 24 | 2025-03-07actual | — | 2025-07-23 |
| Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)NCT02112656results2024-08-20Overall Survival (OS)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ThermoDox, Dummy infusion | Hepatocellular Carcinoma | 554 | 2020-04-27actual | — | 2024-08-20 |
| Heat-Activated Target Therapy of Local-Regional Relapse in Breast Cancer PatientsNCT02850419Number of participants with treatment-related adverse events as assessed by CTCAE v4.0Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Administrative | Drug: ThermoDox (Thermally Sensitive Liposomal Doxorubicin) · Radiation: Radiation Therapy · Device: Superficial Hyperthermia | Breast Cancer | 0 | Dec 2019 | — | 2022-04-07 |
| Study of Safety & Biological Activity of IP IMNN-001 (also Known As GEN-1) with Neoadjuvant Chemo in Ovarian CancerNCT02480374DLTOpen-label · Treatment | Phase 1 | Completed | Biological: IMNN-001 | Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer | 18 | May 2017actual | — | 2024-10-02 |
| Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest WallNCT00826085To determine the bioequivalence of ThermoDox when used with hyperthermia among patients with RCW breast cancer.Open-label · Treatment | Phase 1/2 | Completed | Drug: ThermoDox in combination with Microwave Hyperthermia (heat) | Breast Cancer | 17 | Dec 2015actual | — | 2017-01-30 |
| MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone MetastasesNCT01640847Rate of complete pain responseNon-randomized · Open-label · Treatment | Phase 2 | Withdrawn | Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox | Painful Bone Metastases, Breast Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Adenocarcinoma | 0 | Jun 2013actual | — | 2017-02-07 |
| Phase 2 Study of Thermodox as Adjuvant Therapy With Thermal Ablation (RFA) in Treatment of Metastatic Colorectal Cancer(mCRC)NCT01464593results2022-10-13Determine the Local Tumor Control at 1 Year Post RandomizationOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: trial design contingent on RFA optimization | Drug: Lyso-Thermosensitive Liposomal Doxorubicin, ThermoDox · Other: 5% Dextrose Solution | Colon Cancer Liver Metastasis | 2 | May 2013actual | — | 2022-10-13 |
| Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC)NCT00617981results2017-03-24Progression Free Survival Will be Measured From the Date of Randomization to the First Date on Which One of the Following Occurs. o Local Recurrence o Any New Distant Intrahepatic HCC Tumor o Any New Extrahepatic HCC Tumor o Death From Any CauseRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: ThermoDox, 5% Dextrose Solution | Hepatocellular Carcinoma | 701 | Jan 2013actual | — | 2024-05-03 |
| A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the LiverNCT00441376To determine the maximum tolerated dose (MTD) of systemically delivered, heat-activated liposome encapsulated doxorubicin (ThermoDox) in combination with radiofrequency ablation (RFA) of liver neoplasms.Open-label · Treatment | Phase 1 | Completed | Drug: ThermoDox | Hepatocellular Carcinoma, Liver Neoplasms | 30 | Oct 2008actual | — | 2019-02-07 |
| Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast CancerNCT00036985Randomized · Open-label · Treatment | Phase 2 | Unknown status | Drug: cyclophosphamide, doxorubicin hydrochloride · Procedure: conventional surgery, neoadjuvant therapy, thermal ablation therapy | Breast Cancer | — | — | — | 2013-12-19 |
| Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast CancerNCT00036998Randomized · Open-label · Treatment | Phase 2 | Unknown status | Procedure: conventional surgery, neoadjuvant therapy, thermal ablation therapy | Breast Cancer | — | — | — | 2013-11-06 |
| Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate CancerNCT00061867Open-label · Treatment | Phase 1 | Completed | Drug: pegylated liposomal doxorubicin hydrochloride · Procedure: hyperthermia treatment | Prostate Cancer | — | — | — | 2013-05-30 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19