32 completed, 13 terminated, 6 recruiting, 3 active not recruiting. 30 Phase 1, 18 Phase 2, 9 Phase 3, 5 Not applicable.
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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 |
|---|---|---|---|---|---|---|
| Renal Impairment Pharmacokinetics (PK) Trial of Afabicin Afabicin Oral, Afabicin IV - Renal Impairment | Phase 1 | Not yet recruiting | Debiopharm International SA | 60 | 2026-09-01 | 2026-09-22 |
| A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs Debio 4126, Placebo - Acromegaly | Phase 3 | Recruiting | Debiopharm International SA | 119 | 2025-11-26 | 2026-09-22 |
| A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults Debio 1453P, Placebo - Healthy Participants | Phase 1 | Recruiting | Debiopharm International SA | 88 | 2025-06-18 | 2026-09-22 |
| A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML) Debio 1562M - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Recruiting | Debiopharm International SA | 154 | 2025-05-30 | 2026-09-11 |
| Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer Debio 0123 and Sacituzumab govitecan - Advanced Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | MedSIR | 76 | 2025-01-17 | 2025-12-05 |
| Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients Goserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg - Triple Negative Breast Cancer, Premenopausal Breast Cancer | Phase 2 | Recruiting | National Taiwan University Hospital | 124 | 2024-08-22 | 2025-04-29 |
| A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial) Debio 4326 - Central Precocious Puberty | Phase 3 | Active not recruiting | Debiopharm International SA | 56 | 2024-07-31 | 2026-09-22 |
| A Dose Finding Study of Debio 4228 in Participants With Advanced Prostate Cancer Debio 4228 - Prostate Cancer | Phase 2 | Completed | Debiopharm International SA | 55 | 2024-05-23 | 2026-08-24 |
| A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma Debio 0123, Temozolomide, Radiotherapy - Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Astrocytoma, Grade III | Phase 1 / Phase 2 | Recruiting | Debiopharm International SA | 116 | 2023-05-15 | 2026-09-22 |
| Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy Debio 0123, Etoposide, Carboplatin - Small Cell Lung Cancer Recurrent | Phase 1 | Terminated | Debiopharm International SA | 34 | 2023-05-02 | 2026-05-04 |
| Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy, Androgen deprivation therapy - Recurrent Prostate Cancer | Not applicable | Active not recruiting | Insel Gruppe AG, University Hospital Bern | 36 | 2023-03-29 | 2025-12-31 |
| Study of RP-6306 With FOLFIRI in Advanced Solid Tumors RP-6306 (oral PKMYT1 inhibitor) - Advanced Solid Tumor | Phase 1 | Terminated | Debiopharm International SA | 38 | 2022-08-09 | 2025-12-05 |
| A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) Debio 4126, Sandostatin LAR, Somatuline ATG - Acromegaly, GEP-NET | Phase 1 | Terminated | Debiopharm International SA | 19 | 2022-05-18 | 2025-11-17 |
| Study of RP-6306 With Gemcitabine in Advanced Solid Tumors RP-6306 (oral PKMYT1 inhibitor) - Adult Solid Tumor | Phase 1 | Terminated | Debiopharm International SA | 67 | 2021-12-16 | 2025-12-05 |
| A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors Debio 0123 - Advanced Solid Tumors | Phase 1 | Terminated | Debiopharm International SA | 93 | 2021-11-05 | 2026-06-23 |
| A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants Radiolabelled Xevinapant 200 mg (Oral Solution), Radiolabelled Xevinapant 100 μg (IV Solution), Xevinapant 200 mg (Oral Solution) - Healthy Volunteers | Phase 1 | Completed | Debiopharm International SA | 12 | 2021-08-02 | 2021-12-27 |
| Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors Lunresertib, RP-3500, Debio0123 - Advanced Solid Tumor | Phase 1 | Recruiting | Debiopharm International SA | 464 | 2021-04-30 | 2026-09-22 |
| Evaluation of Alisporivir for the Treatment of Hospitalised Patients With Infections Due to SARS-CoV-2 (COVID-19) Alisporivir, Standard of care (SOC) - SARS-CoV-2 | Phase 2 | Completed | Assistance Publique - Hôpitaux de Paris | 26 | 2021-01-08 | 2023-05-11 |
| Pembrolizumab In Combination With Debio 1143 In Pancreatic and Colorectal Advanced/Metastatic Adenocarcinoma Pembrolizumab, DEBIO1143 - Adenocarcinoma of the Pancreas, Adenocarcinoma of the Colon | Phase 1 | Completed | Centre Leon Berard | 54 | 2019-09-15 | 2023-02-17 |
| Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors Debio 0123, Carboplatin - Advanced Solid Tumors | Phase 1 | Terminated | Debiopharm International SA | 76 | 2019-07-30 | 2025-12-05 |
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Hepatitis C (10) · Hepatitis C, Chronic (7) · Prostatic Neoplasms (4) · Bacterial Infections (3) · Neoplasms (3) · Acromegaly (2) · Carcinoma, Non-Small-Cell Lung (2) · Heart Failure (2) · Hepatitis (2) · Liver Diseases (2) · Lymphoma (2) · Lymphoma, Follicular (2) · Puberty, Precocious (2) · Alzheimer Disease (1) · Astrocytoma (1)
alisporivir (13) · Ribavirin (9) · afabicin (7) · peginterferon alfa-2a (7) · N-benzhydryl-5-(2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo(1,2-a)(1,5)diazocine-8-carboxamide (5) · CH5183284 (3) · Carboplatin (3) · Triptorelin Pamoate (3) · CUDC 305 (2) · Cisplatin (2) · Gemcitabine (2) · Istaroxime (2) · Linezolid (2) · Radiotherapy (2) · Androgen Antagonists (1)
United States (31) · Spain (20) · France (19) · United Kingdom (18) · Poland (11) · Germany (10) · Italy (10) · Canada (9) · Belgium (8) · Romania (7) · Taiwan (7) · Australia (6) · Hungary (5) · South Korea (5) · Switzerland (5)
Azra Hussaini, MD (1) · Barry Reiner, MD (1) · Claudio Zanna, MD (1) · David Domek, MD (1) · Dennis Brenner, MD (1) · Diane Merritt, MD (1) · Douglas Rogers, MD (1) · Eija Lundstrom, MD (1) · Emmanuel Tamches, MD (1) · Enriqueta Felip, PR (1) · Erica Eugster, MD (1) · Fernando Cassorla, MD (1)
PMID 19888782, PMID 25646368, PMID 25716544, PMID 26118427, PMID 30559136, PMID 32747361, PMID 32758455, PMID 34389694, PMID 36796234, PMID 37439181, PMID 37777832, PMID 38296279, PMID 40351326
2018 (3), 2015 (2), 2008 (1), 2009 (1), 2017 (1), 2023 (1)