Clinical trials
catalyst calendar across sponsors →Studies where CELC is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
4 interventional · 1 expanded access
Held by 12 tracked-famous managers (Point72 Asset Management, L.P., Holocene Advisors, LP, Artisan Partners Limited Partnership, MARSHALL WACE, LLP, SUSQUEHANNA INTERNATIONAL GROUP, LLP, +7 more) · FINRA short interest 6.8 days to cover (settled 2026-07-31) · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)NCT06757634Progression Free Survival (PFS)Randomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole, Arm D: Ribociclib + Letrozole | Breast Cancer | 1,180 | 2029-03-31 | in 955 d | 2026-05-18 |
| Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate CancerNCT06190899Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)Randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: Gedatolisib, Darolutamide | mCRPC (Metastatic Castration-resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male, Prostatic Disease, Prostatic Neoplasms, Castration-Resistant, Prostate Cancer | 54 | Jan 2028 | ≤ 530 d | 2026-04-13 |
| Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)NCT05501886Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast CancerRandomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Drug: Gedatolisib, Palbociclib, Fulvestrant, Alpelisib | Breast Cancer | 701 | 2026-06-30 | — | 2026-02-10 |
| A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast CancerNCT02684032Number of participants with dose limiting toxicitiesNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Gedatolisib, Palbociclib, Letrozole, Fulvestrant | Breast Cancer | 141 | 2022-01-19actual | — | 2022-07-27 |
| Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009NCT05134922expanded access | — | Available | Drug: Gedatolisib | Breast Neoplasm Malignant Female | — | — | — | 2025-03-21 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19