10 completed, 3 terminated, 2 not yet recruiting, 1 recruiting. 13 Phase 1, 10 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Completed 7, Terminated 3, Not yet recruiting 2, Recruiting 1 |
| Phase 2 | 10 | Completed 7, Terminated 2, Not yet recruiting 1 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs ATRN-119, Stereotactic Body Radiation Therapy (SBRT) - HPV Positive Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma | Phase 1 / Phase 2 | Not yet recruiting | Abramson Cancer Center at Penn Medicine | 35 | 2026-08-31 | 2026-07-08 |
| ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS ATRN-119, Decitabine - Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome | Phase 1 | Not yet recruiting | Washington University School of Medicine | 27 | 2026-08-31 | 2026-06-01 |
| Study of APR-1051 in Patients With Advanced Solid Tumors APR-1051 - Advanced Solid Tumor | Phase 1 | Recruiting | Aprea Therapeutics | 90 | 2024-06-13 | 2026-10-09 |
| Study Of ATRN-119 In Patients With Advanced Solid Tumors ATRN-119 - Advanced Solid Tumor | Phase 1 / Phase 2 | Completed | Aprea Therapeutics | 43 | 2023-01-09 | 2026-08-04 |
| APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS) APR-548 + Azacitidine - MDS, Myelodysplastic Syndromes | Phase 1 | Terminated | Aprea Therapeutics | 4 | 2021-09-20 | 2025-03-10 |
| APR-246 in Combination With Acalabrutinib or Venetoclax Based Therapy in Subjects With R/R Non Hodgkin Lymphomas (NHL) APR-246 (eprenetapopt) + Acalabrutinib in CLL, APR-246 (eprenetapopt) 4.5 g/d + Venetoclax + Rituximab in CLL, APR-246 (eprenetapopt) 4.5 g/d + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT - Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia | Phase 1 / Phase 2 | Terminated | Aprea Therapeutics | 1 | 2021-03-02 | 2025-03-17 |
| Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies APR-246 (eprenetapopt) + Pembrolizumab - Bladder Cancer, Gastric Cancer | Phase 1 / Phase 2 | Completed | Aprea Therapeutics | 40 | 2020-06-25 | 2025-05-13 |
| APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies APR-246, Venetoclax, Azacitidine - Myeloid Malignancy | Phase 1 | Completed | Aprea Therapeutics | 51 | 2019-12-13 | 2025-03-17 |
| APR-246 in Combination With Azacitidine for TP53 Mutated AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) Following Allogeneic Stem Cell Transplant APR-246 - Acute Myeloid Leukemia or Myelodysplastic Syndromes | Phase 2 | Completed | Aprea Therapeutics | 33 | 2019-09-16 | 2025-03-17 |
| APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS) APR-246 + azacitidine, Azacitidine - MDS | Phase 3 | Completed | Aprea Therapeutics | 154 | 2019-01-11 | 2025-03-18 |
| Study of the Safety and Efficacy of APR-246 in Combination With Azacitidine APR-246, Azacitidine - Myelodysplastic Syndrome With Gene Mutation, Acute Myeloid Leukemia With Gene Mutations | Phase 1 / Phase 2 | Completed | Groupe Francophone des Myelodysplasies | 53 | 2018-09-15 | 2026-09-21 |
| A Study of APR-246 in Combination With Dabrafenib in Resistant Patients With BRAF V600 Mutant Melanoma APR-246, Dabrafenib - Melanoma | Phase 1 / Phase 2 | Terminated | Aprea Therapeutics | 3 | 2018-01-18 | 2019-07-31 |
| p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246 APR-246, Pegylated Liposomal Doxorubicin Hydrochloride (PLD) - High-grade Serous Ovarian Cancer | Phase 2 | Completed | Aprea Therapeutics | 36 | 2017-07-31 | 2025-03-17 |
| Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms APR-246, Azacitidine - Myelodysplastic Syndrome, Acute Myeloid Leukemia | Phase 1 / Phase 2 | Completed | H. Lee Moffitt Cancer Center and Research Institute | 55 | 2017-05-18 | 2022-01-24 |
| p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 APR-246, Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD) - Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53 | Phase 1 / Phase 2 | Completed | Aprea Therapeutics | 247 | 2014-03-01 | 2025-03-17 |
| Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer APR-246 - Hematologic Neoplasms, Prostatic Neoplasms | Phase 1 | Completed | Aprea Therapeutics | 36 | 2009-05-01 | 2019-07-31 |
Leukemia, Myeloid, Acute (3) · Myelodysplastic Syndromes (3) · Leukemia, Myelomonocytic, Chronic (2) · Myeloproliferative Disorders (2) · Ovarian Neoplasms (2) · Recurrence (2) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Squamous Cell (1) · Carcinoma, Transitional Cell (1) · Hematologic Neoplasms (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Lymphoma, Mantle-Cell (1) · Lymphoma, Non-Hodgkin (1) · Melanoma (1) · Neoplasm Metastasis (1)
eprenetapopt (11) · Azacitidine (6) · venetoclax (2) · Carboplatin (1) · Decitabine (1) · Radiosurgery (1) · Rituximab (1) · acalabrutinib (1) · dabrafenib (1) · pembrolizumab (1)
United States (11) · Belgium (3) · France (3) · Spain (2) · Sweden (2) · United Kingdom (2) · Germany (1) · Netherlands (1)
Joachim Gullbo, MD (3) · Ahmad Awada, PhD (1) · Asmita Mishra, MD, PhD (1) · Charlie Gourley, BSc, MB ChB, PhD, FRCP (1) · Crystal Miller, RN BSN (1) · David Sallman, M.D. (1) · David Sallman, MD, PhD (1) · Geoffrey L Uy, MD (1) · Joseph Kerger, MD (1) · Pierre Fenaux (1)
PMID 33449813, PMID 33600210, PMID 35816664, PMID 36084396, PMID 36990622
P50CA171963 (1)