7 completed, 2 active not recruiting, 2 withdrawn, 1 recruiting. 5 Phase 1, 5 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 3, Recruiting 1, Terminated 1 |
| Phase 2 | 5 | Completed 4, Active not recruiting 1 |
| Phase 3 | 3 | Withdrawn 2, Active not recruiting 1 |
Follow TVB-2640: new trials by email Literature Review of TVB-2640 trials Research Report on TVB-2640
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 |
|---|---|---|---|---|---|---|
| A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis Denifanstat, Placebo - MASH, NASH | Phase 3 | Withdrawn | Sagimet Biosciences Inc. | 2025-03-01 | 2025-05-15 | |
| A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH denifanstat, Placebo - MASLD, MASH | Phase 3 | Withdrawn | Sagimet Biosciences Inc. | 2025-03-01 | 2025-05-15 | |
| Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer TVB-2640, Enzalutamide - Prostatic Neoplasms, Castration-Resistant | Phase 1 | Recruiting | Weill Medical College of Cornell University | 30 | 2023-11-20 | 2025-11-21 |
| A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function TVB-2640 - 50 mg - Non-alcoholic Steatohepatitis, Hepatic Impairment | Phase 1 | Completed | Sagimet Biosciences Inc. | 48 | 2023-05-01 | 2023-12-26 |
| Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM ASC40 tablets, Placebo tablets, Bevacizumab - Recurrent Glioblastoma | Phase 3 | Active not recruiting | Ascletis Pharmaceuticals Co., Ltd. | 136 | 2022-01-21 | 2024-10-31 |
| Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH) TVB-2640, Placebo - Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease | Phase 2 | Completed | Sagimet Biosciences Inc. | 168 | 2021-08-12 | 2025-05-09 |
| Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects TVB-2640, Placebo - Healthy | Phase 1 | Completed | Ascletis Pharmaceuticals Co., Ltd. | 34 | 2020-04-02 | 2020-07-07 |
| Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas TVB-2640 - KRAS Gene Mutation | Phase 2 | Active not recruiting | David E Gerber | 18 | 2019-09-11 | 2026-05-22 |
| Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH) TVB-2640 25 mg (US), TVB-2640 50 mg (US), Placebo (US) - MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) | Phase 2 | Completed | Sagimet Biosciences Inc. | 142 | 2019-03-22 | 2024-12-19 |
| TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial. TVB-2640, Placebo - Colon Cancer | Phase 1 | Terminated | Mark Evers | 23 | 2017-10-06 | 2024-10-22 |
| TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer Anastrozole, Denifanstat, Exemestane - Advanced Breast Carcinoma, HER2-Positive Breast Carcinoma | Phase 2 | Completed | Mayo Clinic | 17 | 2017-08-03 | 2026-10-09 |
| TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma Bevacizumab, TVB-2640 - Astrocytoma | Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 25 | 2017-05-18 | 2023-06-15 |
| A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors TVB-2640 - Solid Malignant Tumor | Phase 1 | Completed | Sagimet Biosciences Inc. | 180 | 2013-11-01 | 2017-08-14 |
Non-alcoholic Fatty Liver Disease (5) · Fatty Liver (4) · Fibrosis (2) · Liver Diseases (2) · Astrocytoma (1) · Colonic Neoplasms (1) · Digestive System Diseases (1) · Glioblastoma (1) · Neoplasms (1) · Prostatic Neoplasms, Castration-Resistant (1)
Sagimet Biosciences Inc. (6) · Ascletis Pharmaceuticals Co., Ltd. (2) · David E Gerber (1) · Mark Evers (1) · Mayo Clinic (1) · The University of Texas Health Science Center at San Antonio (1) · Weill Medical College of Cornell University (1)
United States (9) · China (3) · Canada (1) · Hungary (1) · Poland (1) · Puerto Rico (1) · United Kingdom (1)
Andrew Brenner (1) · David Gerber, MD (1) · David Nanus, M.D. (1) · Jeffrey R Infante, MD (1) · Mark B Evers, MD (1) · Rohit Loomba, MD (1) · Tufia C. Haddad, M.D. (1) · Yahong Chen, MD (1)
PMID 40404984, PMID 33870151, PMID 34310978
R01CA208343 (1)