26 completed, 18 terminated, 14 active not recruiting, 12 recruiting. 75 Phase 1, 27 Phase 2.
Follow ribociclib: new trials by email Literature Review of ribociclib trials Research Report on ribociclib
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 Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors ATX-898, ATX-898, fulvestrant, ribociclib - Advanced Solid Tumors | Phase 1 / Phase 2 | Recruiting | Antares Therapeutics, Inc | 343 | 2026-08-31 | 2026-10-16 |
| Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer Ribociclib 400mg, Ribociclib 600mg - Breast Cancer | Phase 1 / Phase 2 | Recruiting | Nagoya City University | 86 | 2025-10-01 | 2026-04-13 |
| A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet - Metastatic Breast Cancer, Breast Cancer Stage I | Phase 1 / Phase 2 | Recruiting | Forward Pharmaceuticals Co., Ltd. | 196 | 2025-06-01 | 2026-01-07 |
| Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and in Patients With Other Advanced Solid Tumors ECI830, ribociclib, fulvestrant - Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors | Phase 1 / Phase 2 | Recruiting | Novartis Pharmaceuticals | 280 | 2025-04-03 | 2026-08-27 |
| Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors BBO-10203, Trastuzumab, Fulvestrant - Solid Tumor, Adult, Metastatic Breast Cancer | Phase 1 | Recruiting | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | 392 | 2024-10-29 | 2026-10-01 |
| Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer Ribociclib, Postoperative Radiation Therapy - Breast Cancer | Phase 1 | Active not recruiting | University of Michigan Rogel Cancer Center | 32 | 2024-02-27 | 2026-10-15 |
| First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer OKI-219, Fulvestrant, Trastuzumab - Advanced Cancer, Breast Cancer | Phase 1 | Active not recruiting | OnKure, Inc. | 200 | 2024-02-26 | 2026-07-06 |
| A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors AZD8421, Camizestrant, Ribociclib - ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC) | Phase 1 / Phase 2 | Active not recruiting | AstraZeneca | 55 | 2023-12-05 | 2026-10-28 |
| [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Ribociclib - Breast Cancer | Phase 1 | Active not recruiting | Novartis Pharmaceuticals | 28 | 2023-11-13 | 2026-09-11 |
| Study of AVZO-021 in Patients With Advanced Solid Tumors AVZO-021, Palbociclib, Fulvestrant - Advanced Solid Tumor, HR+/HER2- Breast Cancer | Phase 1 / Phase 2 | Recruiting | Avenzo Therapeutics, Inc. | 430 | 2023-08-30 | 2026-09-28 |
| Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS) Ribociclib Oral Tablet - HER2 Negative Breast Cancer Not Immediately Operated | Phase 1 / Phase 2 | Withdrawn | Centre Antoine Lacassagne | 2023-06-26 | 2026-04-15 | |
| First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors STX-478, Fulvestrant, Ribociclib - Breast Cancer, Solid Tumors, Adult | Phase 1 / Phase 2 | Recruiting | Eli Lilly and Company | 880 | 2023-04-17 | 2026-07-07 |
| First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors RLY-5836, Fulvestrant, Palbociclib - PIK3CA Mutation, Solid Tumor, Adult | Phase 1 | Completed | Relay Therapeutics, Inc. | 41 | 2023-03-29 | 2025-05-16 |
| TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) ARV-471, Ribociclib - Breast Cancer | Phase 1 / Phase 2 | Terminated | Pfizer | 20 | 2023-03-01 | 2026-10-27 |
| A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer TOS-358, Fulvestrant, Palbociclib - HR+/HER2-negative Breast Cancer | Phase 1 | Recruiting | Totus Medicines | 241 | 2023-02-15 | 2026-04-22 |
| Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer Elacestrant, Alpelisib, Everolimus - Breast Cancer, Metastatic Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Stemline Therapeutics, Inc. | 435 | 2023-01-24 | 2026-06-12 |
| Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer TTI-101, Palbociclib, Aromatase inhibitor (AI) - Breast Cancer | Phase 1 | Terminated | Tvardi Therapeutics, Incorporated | 6 | 2023-01-09 | 2026-09-24 |
| Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors Topotecan, Temozolomide, Ribociclib - Neuroblastoma | Phase 1 | Terminated | Novartis Pharmaceuticals | 12 | 2022-12-27 | 2025-10-10 |
| Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation JDQ443, trametinib, Ribociclib - KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung | Phase 1 / Phase 2 | Terminated | Novartis Pharmaceuticals | 74 | 2022-10-24 | 2026-10-21 |
| Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer Palazestrant, Ribociclib, Alpelisib - Metastatic Breast Cancer, ER-positive Breast Cancer | Phase 1 | Active not recruiting | Olema Pharmaceuticals, Inc. | 190 | 2022-08-31 | 2026-09-15 |
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Breast Neoplasms (32) · Glioma (6) · Neoplasm Metastasis (6) · Neoplasms (6) · Carcinoma, Non-Small-Cell Lung (5) · Colorectal Neoplasms (4) · Ovarian Neoplasms (4) · Squamous Cell Carcinoma of Head and Neck (4) · Carcinoma, Ovarian Epithelial (3) · Diffuse Intrinsic Pontine Glioma (3) · Endometrial Neoplasms (3) · Glioblastoma (3) · Medulloblastoma (3) · Neuroblastoma (3) · Recurrence (3)
Novartis Pharmaceuticals (23) · Dana-Farber Cancer Institute (3) · Pfizer (3) · AstraZeneca (2) · Children's Hospital Medical Center, Cincinnati (2) · Hoffmann-La Roche (2) · Relay Therapeutics, Inc. (2) · Abramson Cancer Center at Penn Medicine (1) · Antares Therapeutics, Inc (1) · Array BioPharma (1) · Avenzo Therapeutics, Inc. (1) · Blueprint Medicines Corporation (1) · Centre Antoine Lacassagne (1) · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (1) · Eli Lilly and Company (1)
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