6 completed, 3 recruiting, 3 terminated, 3 unknown. 12 Phase 2, 7 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 5, Unknown 3, Recruiting 2, Terminated 2 |
| Phase 1 | 7 | Completed 4, Terminated 2, Withdrawn 1 |
| Phase 3 | 2 | Active not recruiting 1, Recruiting 1 |
Follow HBI-8000: new trials by email Literature Review of HBI-8000 trials Research Report on HBI-8000
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 |
|---|---|---|---|---|---|---|
| Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP Chidamide, Entecavir Tablets - Diffuse Large B-Cell Lymphoma (DLBCL) | Phase 3 | Recruiting | Ou Bai, MD/PHD | 200 | 2026-05-30 | 2026-03-25 |
| Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL Chidamide, Rituximab, Cyclophosphamide - Diffuse Large B-Cell Lymphoma (DLBCL) | Phase 2 | Recruiting | Ou Bai, MD/PHD | 50 | 2026-04-30 | 2026-03-25 |
| Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL) Chidamide - Relapsed or Refractory Peripheral T-cell Lymphoma | Phase 2 | Recruiting | Great Novel Therapeutics Biotech & Medicals Corporation | 33 | 2024-10-18 | 2026-07-07 |
| Chidamide + Regorafenib in Hepatocellular Carcinoma (HCC) Chidamide, Regorafenib - Hepatocellular Carcinoma (HCC) | Phase 1 / Phase 2 | Terminated | Great Novel Therapeutics Biotech & Medicals Corporation | 7 | 2023-04-25 | 2025-03-11 |
| Chidamide + Celecoxib in Advanced Metastatic Colorectal Cancer (CCmCC) chidamide, celecoxib - Metastatic Colorectal Cancer | Phase 1 | Terminated | Taipei Medical University Shuang Ho Hospital | 9 | 2022-09-20 | 2024-12-20 |
| A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer HBI-8000 in combination with pembrolizumab - Non Small Cell Lung Cancer | Phase 2 | Terminated | HUYABIO International, LLC. | 5 | 2022-02-15 | 2025-12-24 |
| Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma HBI-8000 in combination with nivolumab, Placebo in combination with nivolumab - Unresectable or Metastatic Melanoma, Progressive Brain Metastasis | Phase 3 | Active not recruiting | HUYABIO International, LLC. | 450 | 2021-08-12 | 2025-09-24 |
| A Clinical Trial of Chidamide in the Management of Refractory ITP Chidamide - Thrombocytopenia | Phase 1 / Phase 2 | Completed | Shandong University | 61 | 2021-06-01 | 2025-08-26 |
| Chidamide Plus PTCy/Cyclosporine to Prevent GVHD After Myeloablative Conditioning, Matched PBSCT Chidamide, Cyclophosphamide, cyclosporine A - Leukemia, Acute, MDS | Phase 2 | Unknown | Sichuan University | 50 | 2019-01-01 | 2018-07-18 |
| Phase 2 Trial of Chidamide-Lenalidomide-Dexamethasone(CRD) Regimen in R/R MM chidamide, lenalidomide, dexamethasone - Multiple Myeloma | Phase 2 | Unknown | Peng Liu | 25 | 2018-07-31 | 2018-07-30 |
| Chidamide With R-CHOP Regimen for DLBCL Patients Chidamide + R-CHOP regimen - Diffuse Large B Cell Lymphoma | Phase 2 | Unknown | First Affiliated Hospital of Zhejiang University | 39 | 2017-08-20 | 2018-08-02 |
| Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) HBI-8000 - Peripheral T-Cell Lymphoma (PTCL) | Phase 2 | Completed | HUYABIO International, LLC. | 55 | 2016-11-01 | 2024-09-19 |
| Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL) HBI-8000 - Adult T-Cell Lymphoma (ATL) | Phase 2 | Completed | HUYABIO International, LLC. | 23 | 2016-11-01 | 2024-09-19 |
| Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer HBI-8000 in combination with nivolumab - Melanoma, Renal Cell Carcinoma | Phase 1 / Phase 2 | Completed | HUYABIO International, LLC. | 96 | 2016-08-18 | 2026-07-30 |
| Dose Escalation Study of HBI-8000 in Combination With Paclitaxel and Trastuzumab in Women With Advanced or Metastatic HER2+ Breast Cancer HBI-8000, Trastuzumab, Paclitaxel - Breast Cancer | Phase 1 | Withdrawn | HUYABIO International, LLC. | 2015-12-01 | 2022-07-18 | |
| Chidamide in Combination With Antiretroviral Therapy for Eradication of the Latent HIV-1 Reservoir Chidamide - Chronic HIV Infections | Phase 1 / Phase 2 | Completed | Tang-Du Hospital | 13 | 2015-08-01 | 2020-01-18 |
| Safety Study of HBI-8000 in Japanese Patients With Non Hodgkin's Lymphoma HBI-8000 - Non-Hodgkin's Lymphoma | Phase 1 | Completed | HUYABIO International, LLC. | 13 | 2014-03-01 | 2017-01-12 |
Lymphoma, Large B-Cell, Diffuse (3) · Carcinoma, Non-Small-Cell Lung (2) · Lymphoma, T-Cell, Peripheral (2) · Melanoma (2) · Brain Neoplasms (1) · Breast Neoplasms (1) · Carcinoma, Hepatocellular (1) · Carcinoma, Renal Cell (1) · Colorectal Neoplasms (1) · Leukemia (1) · Lymphoma, Non-Hodgkin (1) · Multiple Myeloma (1) · Precursor T-Cell Lymphoblastic Leukemia-Lymphoma (1) · Recurrence (1) · Thrombocytopenia (1)
HUYABIO International, LLC. (7) · Great Novel Therapeutics Biotech & Medicals Corporation (2) · Ou Bai, MD/PHD (2) · First Affiliated Hospital of Zhejiang University (1) · Peng Liu (1) · Shandong University (1) · Sichuan University (1) · Taipei Medical University Shuang Ho Hospital (1) · Tang-Du Hospital (1)
China (7) · Japan (4) · Taiwan (3) · United States (3) · South Korea (2) · Australia (1) · Austria (1) · Belgium (1) · Brazil (1) · Czechia (1) · France (1) · Germany (1) · Italy (1) · New Zealand (1) · Puerto Rico (1)
Chia-Nan Chen, Ph.D. (2) · Gloria Lee, MD (2) · Gloria Lee, MD, PhD (2) · Ou Bai, PHD (2) · Kensei Tobinai, MD (1) · Nikhil I Khushalani, MD (1) · Peng Liu, MD,PhD (1) · Ting Liu, MD (1) · Yongtao Sun, M.D., Ph.D. (1)