5 completed, 5 recruiting, 3 active not recruiting, 3 not yet recruiting. 10 Phase 1, 8 Phase 2, 4 Phase 3, 1 Early Phase 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 |
|---|---|---|---|---|---|---|
| Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma Safusidenib, Placebo - Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2 | Phase 3 | Not yet recruiting | Nuvation Bio Inc. | 140 | 2027-03-01 | 2026-07-17 |
| Safusidenib for Patients With Newly Diagnosed IDH1-mutant CNS WHO Grade 3 Oligodendroglioma and Astrocytoma - a Single Arm Phase II Study Safusidenib - Glioma : Oligodendroglioma or Astrocytoma | Phase 2 | Not yet recruiting | University of Zurich | 20 | 2027-03-01 | 2026-09-21 |
| Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease Safusidenib - Grade 2 IDH1-mutant Glioma, Grade 3 IDH1-mutant Glioma | Phase 2 | Recruiting | Nuvation Bio Inc. | 40 | 2027-03-01 | 2026-10-20 |
| Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib Taletrectinib, Taletrectinib, Famotidine, Taletrectinib,Famotidine - Healthy Adult Participants | Phase 1 | Not yet recruiting | Nuvation Bio Inc. | 56 | 2026-08-01 | 2026-08-03 |
| Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) Taletrectinib, Placebo - Non-small Cell Lung Cancer (NSCLC) | Phase 3 | Recruiting | Nuvation Bio Inc. | 180 | 2025-08-21 | 2026-05-19 |
| A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Taletrectinib, Crizotinib - Non Small Cell Lung Cancer | Phase 3 | Recruiting | Nuvation Bio Inc. | 194 | 2024-11-27 | 2026-04-13 |
| Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors NUV-1511 - Advanced Solid Tumor, HER2-negative Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Nuvation Bio Inc. | 466 | 2024-03-14 | 2026-01-14 |
| SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) safusidenib, Placebo - Glioma, Astrocytoma, Grade IV | Phase 3 | Recruiting | Nuvation Bio Inc. | 365 | 2023-06-05 | 2026-10-19 |
| Study the Effect of Omeprazole on AB-106 Pharmacokinetics Multiple administration of omeprazole Single administration of AB-106 - Pharmacokinetic Study | Phase 1 | Completed | Nuvation Bio Inc. | 24 | 2022-11-02 | 2024-11-21 |
| A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma Biopsy, Part A: Safusidenib Erbumine, Surgery (maximal resection) - Glioma | Early Phase 1 | Completed | Melbourne Health | 14 | 2022-10-11 | 2026-03-18 |
| Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC NUV-422, Enzalutamide - Prostate Cancer, Prostatic Cancer | Phase 1 / Phase 2 | Withdrawn | Nuvation Bio Inc. | 2022-09-01 | 2022-08-05 | |
| Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC NUV-422, Fulvestrant - Advanced Breast Cancer, Metastatic Breast Cancer | Phase 1 / Phase 2 | Withdrawn | Nuvation Bio Inc. | 2022-09-01 | 2023-07-11 | |
| NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors NUV-868, Olaparib, Enzalutamide - Advanced Solid Tumor, Ovarian Cancer | Phase 1 | Terminated | Nuvation Bio Inc. | 82 | 2022-03-29 | 2025-11-06 |
| Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC Taletrectinib - Non Small Cell Lung Cancer | Phase 2 | Active not recruiting | Nuvation Bio Inc. | 217 | 2021-09-01 | 2026-01-07 |
| A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK AB-106, Itraconazole, AB-106, Rifampicin - Solid Tumor | Phase 1 | Completed | Nuvation Bio Inc. | 56 | 2021-07-19 | 2024-11-21 |
| A Study on the Effect of AB-106 on the Pharmacokinetics of Digoxin AB-106, digoxin - Solid Tumor | Phase 1 | Completed | Nuvation Bio Inc. | 16 | 2021-07-13 | 2024-11-21 |
| Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene Fusion AB-106 - Solid Tumor | Phase 2 | Terminated | Nuvation Bio Inc. | 14 | 2021-06-01 | 2026-01-21 |
| Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors NUV-422 - Glioma, Glioma, Malignant | Phase 1 | Terminated | Nuvation Bio Inc. | 74 | 2020-12-08 | 2023-07-14 |
| A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene AB-106 - Non Small Cell Lung Cancer | Phase 2 | Active not recruiting | Nuvation Bio Inc. | 173 | 2020-07-07 | 2026-02-06 |
| CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS) Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents., Patient-reported outcomes (PROs) - Cancer, Malignancies Multiple | Recruiting | University Health Network, Toronto | 5500 | 2020-01-17 | 2025-12-03 |
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Carcinoma, Non-Small-Cell Lung (5) · Glioma (5) · Oligodendroglioma (5) · Astrocytoma (4) · Breast Neoplasms (3) · Neoplasms (3) · Pancreatic Neoplasms (3) · Prostatic Neoplasms (3) · Prostatic Neoplasms, Castration-Resistant (3) · Glioblastoma (2) · Lung Neoplasms (2) · Carcinoma (1) · Carcinoma, Bronchogenic (1) · Colorectal Neoplasms (1) · Congenital Abnormalities (1)
taletrectinib (5) · enzalutamide (2) · Biopsy (1) · Crizotinib (1) · Digoxin (1) · Famotidine (1) · Fulvestrant (1) · Itraconazole (1) · Patient Reported Outcome Measures (1) · Rifampin (1) · Surgical Procedures, Operative (1) · Tyrosine Kinase Inhibitors (1) · olaparib (1)
United States (10) · China (9) · Australia (3) · Canada (3) · France (1) · Italy (1) · Japan (1) · Poland (1) · South Korea (1) · Spain (1) · Switzerland (1)
Caicun Zhou (1) · Geoffrey Liu, MD, MSc (1) · Kate Drummond, Prof (1) · Michael Weller, MD (1) · Shuangmiao Wang (1) · Wei Wang, MD, PhD (1)
PMID 40179330, PMID 36877099, PMID 38822758, PMID 39140289, PMID 40841487, PMID 42013573