| sotigalimab (PYX-107) / Pyxis Oncology |
| Terminated | 2 | 45 | Europe | sotigalimab, APX005M | Apexigen America, Inc. | Unresectable Melanoma, Metastatic Melanoma, Cancer, Cancer of Skin, Melanoma, Melanoma (Skin) | 07/22 | 08/22 | | |
NCT03165994: APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers |
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| Completed | 2 | 34 | US | APX005M, CD40 Agonistic Monoclonal Antibody, PYX-107, Sotigalimab, Radiation Therapy, Radiotherapy, Paclitaxel, Taxol, Carboplatin, Paraplatin, Surgical resection of tumor, Surgery, Operation | Apexigen America, Inc. | Esophageal Cancer, GastroEsophageal Cancer | 11/22 | 02/23 | | |
| Active, not recruiting | 2 | 27 | US | Doxorubicin, ADRIAMYCIN, APX005M, APX-005M | Alexander Z. Wei, MD, Apexigen America, Inc. | Soft Tissue Sarcoma | 12/24 | 12/25 | | |
| Withdrawn | 2 | 90 | Europe | APX005M, Radiation therapy, carboplatin and PLD | Nordic Society of Gynaecological Oncology - Clinical Trials Unit, Belgian Gynaecological Oncology Group, GSO Global Clinical Research BV, The Central and Eastern European Gynecologic Oncology Group, Swiss GO Trial Group | Ovarian Cancer | 09/23 | 09/23 | | |
2020-005990-29: Immunotherapy and radiation therapy in combination with chemotherapy in relapsed ovarian cancer. |
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| Not yet recruiting | 2 | 90 | Europe | APX005M, Solution for injection | Nordic Society of Gynaecological Oncology - Clinical Trial Unit (NSGO-CTU), Apexigen, Inc. | Patients with histologically diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer with radiologically or histologically confirmation of relapsed disease, and with known BRCA wildtype. Platinum combination therapy must be an option., Patients with relapsed ovarian cancer where platinum combination therapy is an option, Diseases [C] - Cancer [C04] | | | | |
| Active, not recruiting | 2 | 58 | US | APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days, mFOLFOX and Radiation Therapy 5Gy x 5 days | University of Texas Southwestern Medical Center, Apexigen America, Inc. | Locally Advanced Rectal Adenocarcinoma | 09/25 | 09/25 | | |
NCT02706353: APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma |
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| Active, not recruiting | 1/2 | 32 | US | APX005M, Pembrolizumab, Keytruda, MK-3475, SCH-900475 | M.D. Anderson Cancer Center, Apexigen America, Inc., Pyxis Oncology | Melanoma | 04/25 | 04/25 | | |
| Recruiting | 1/2 | 46 | US | ZIMBERELIMAB, AB 122, DOMVANALIMAB, AB 154, APX005M, CD40, FOLFIRI | James Cleary, MD, PhD, Arcus Biosciences, Inc., Lustgarten Foundation | Pancreatic Cancer, Adenocarcinoma of the Pancreas, Squamous Cell Carcinoma of Pancreas, Adenosquamous Carcinoma of the Pancreas | 01/26 | 09/28 | | |
NCT03502330: APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma |
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| Completed | 1 | 42 | US | APX005M, Cabiralizumab, Nivolumab | Yale University, Bristol-Myers Squibb, Apexigen America, Inc., National Cancer Institute (NCI) | Advanced Melanoma, Non-small Cell Lung Cancer, Renal Cell Carcinoma | 01/22 | 05/24 | | |
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NCT03389802: Phase I Study of APX005M in Pediatric CNS Tumors |
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| Active, not recruiting | 1 | 32 | US | APX005M treatment for recurrent or refractory primary malignant CNS tumor patients, APX005M treatment for newly diagnosed DIPG patients | Pediatric Brain Tumor Consortium, American Lebanese Syrian Associated Charities (ALSAC), Pyxis Oncology, Inc, Solving Kids' Cancer, Ty Louis Campbell Foundation, A Kids' Brain Tumor Cure Foundation, National Cancer Institute (NCI) | Glioblastoma Multiforme, High-grade Astrocytoma NOS, CNS Primary Tumor, Nos, Ependymoma, NOS, Diffuse Intrinsic Pontine Gliomas (DIPG), Medulloblastoma | 09/23 | 09/24 | | |
NCT04495257: A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC) |
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| Active, not recruiting | 1 | 26 | US | Nivolumab, Ipilimumab, APX005M | Yale University, Apexigen America, Inc. | Advanced Melanoma, Renal Cell Carcinoma | 08/24 | 02/25 | | |
NCT02600949: Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer |
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| Recruiting | 1 | 150 | US | Imiquimod, Aldara, R 837, S 26308, Zyclara, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Sotigalimab, APX 005, APX 005M, APX-005M, APX005M, CD40 Agonistic Monoclonal Antibody APX005M, EPI-0050, Synthetic Tumor-Associated Peptide Vaccine Therapy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, CT, Magnetic Resonance Imaging, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MR, MRI Scan, Nuclear Magnetic Resonance Imaging, NMR, NMRI, NMR Imaging | M.D. Anderson Cancer Center, National Cancer Institute (NCI) | Metastatic Colorectal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7, Stage IV Pancreatic Cancer AJCC v6 and v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7 | 05/25 | 05/25 | | |
| dexpramipexole (KNS-760704) / Knopp Biosciences, Biogen |
2022-003004-33: Assess the efficacy, safety, & tolerability of oral dexpramipexole in severe eosinophilic asthma |
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| Not yet recruiting | 3 | 1395 | Europe | Dexpramipexole 75mg, Dexpramipexole 150mg, KNS-760704, Film-coated tablet | Areteia Therapeutics, Inc., Areteia Therapeutics, Inc. | Severe Eosinophilic Asthma, Severe Asthma, Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
| Not yet recruiting | 3 | 750 | Europe | Dexpramipexole 75mg, Dexpramipexole 150mg, KNS-760704, Film-coated tablet | Areteia Therapeutics, Inc., Areteia Therapeutics, Inc. | Eosinophilic Asthma, Asthma, Diseases [C] - Respiratory Tract Diseases [C08] | | | | |
EXHALE-4, NCT05748600: A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma |
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| Recruiting | 3 | 550 | Europe, Canada, US, RoW | Dexpramipexole Dihydrochloride, Placebo | Areteia Therapeutics | Eosinophilic Asthma, Asthma; Eosinophilic, Asthma Attack | 03/25 | 04/25 | | |
| Enrolling by invitation | 3 | 1600 | US | Dexpramipexole Dihydrochloride | Areteia Therapeutics | Eosinophilic Asthma | 06/27 | 06/27 | | |
EXHALE-2, NCT05763121: A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. |
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| Recruiting | 3 | 1395 | Europe, US, RoW | Dexpramipexole Dihydrochloride, Placebo | Areteia Therapeutics | Eosinophilic Asthma, Asthma; Eosinophilic, Asthma | 06/26 | 07/26 | | |
EXHALE-3, NCT05813288: A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma |
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| Recruiting | 3 | 930 | Europe, US, RoW | Dexpramipexole Dihydrochloride, Placebo | Areteia Therapeutics | Eosinophilic Asthma, Asthma; Eosinophilic, Asthma | 06/26 | 07/26 | | |
2019-003013-34: Targeting severe asthma sub-types with a view to reducing worsening symptoms, improving asthma control, quality of life and lung function. |
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| Not yet recruiting | 2 | 234 | Europe | Dexpramipexole, Vibrox, KNS-760704, Tablet, Capsule, Vibrox | University of Leicester, National Institute for Health Research, EME, Knopp Biosciences LLC | T2-High and T2-Low severe asthma, Sub-types of severe asthma, Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | | | | |
| Recruiting | 2 | 30 | US | Dexpramipexole Dihydrochloride | Areteia Therapeutics | Chronic Obstructive Pulmonary Disease | 04/25 | 06/25 | | |
| censavudine (TPN-101) / Transposon Therap, Yale University, BMS |
NCT04993755: A Phase 2a Study of TPN-101 in Patients With C9ORF72 ALS/FTD |
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| Active, not recruiting | 2a | 42 | Europe, US | TPN-101, 400 mg/day, Placebo | Transposon Therapeutics, Inc. | Amyotrophic Lateral Sclerosis, Frontotemporal Dementia | 09/23 | 09/23 | | |
NCT04993768: A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP) |
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| Active, not recruiting | 2a | 40 | US | TPN-101, 100 mg/day, TPN-101, 200 mg/day, TPN-101, 400 mg/day, Placebo | Transposon Therapeutics, Inc. | Progressive Supranuclear Palsy | 12/23 | 12/23 | | |
| Recruiting | 2a | 16 | Europe | TPN-101, censavudine | Transposon Therapeutics, Inc. | Aicardi-Goutières Syndrome (AGS) | 12/24 | 04/25 | | |
2021-002251-11: A clinical study to learn whether a new drug, TPN-101, is safe when given to patients with amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion. |
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| Not yet recruiting | 2 | 40 | Europe | TPN-101, TPN-101, Capsule, hard | Transposon Therapeutics, Inc, Transposon Therapeutics, Inc | Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion, Amyotrophic lateral sclerosis or frontotemporal dementia due to a genetic mutation called C9orf72 hexanucleotide repeat expansion, Diseases [C] - Nervous System Diseases [C10] | | | | |
2022-000064-21: A clinical study to learn whether a new drug, TPN-101, is safe when given to AGS patients Studio clinico per scoprire se un nuovo farmaco, TPN-101, sia sicuro quando somministrato ai pazienti con sindrome AGS |
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| Not yet recruiting | 2 | 16 | Europe | TPN-101, [TPN-101], Oral powder | Transposon Therapeutics Inc, Transposon Therapeutics, Inc, Transposon Therapeutics, Inc | Aicardi-Goutières Syndrome (AGS) Sindrome di Aicardi-Goutières (AGS), Aicardi-Goutières Syndrome (AGS) Sindrome di Aicardi-Goutières (AGS), Diseases [C] - Nervous System Diseases [C10] | | | | |
| psilocybin (SYNP-101) / Ceruvia Lifesci |
NCT03341689: Psilocybin for the Treatment of Migraine Headache |
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| Completed | 1 | 14 | US | High Dose Psilocybin, Low Dose Psilocybin, Placebo | Yale University, Ceruvia Lifesciences | Migraine Headache | 04/21 | 10/21 | | |
NCT02981173: Psilocybin for the Treatment of Cluster Headache |
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| Completed | 1 | 25 | US | 0.143 mg/kg Psilocybin or 10 mg Psilocybin, 0.0143 mg/kg Psilocybin or 1 mg Psilocybin, Placebo | Yale University, Heffter Research Institute, Ceruvia Lifesciences, CH TAC LLC | Cluster Headache | 06/22 | 10/22 | | |
