Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
← catalyst calendarNCT06190899 · readout ≤ 530 d
Sponsored by Celcuity Inc (industry) · CELC — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
54estimated
Sites
13
Countries
France, Spain, United Kingdom +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-01-01 | actual | When the study began enrolling |
| Primary completion | Jan 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2024-01-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- mCRPC (Metastatic Castration-resistant Prostate Cancer)
- Genital Diseases, Male
- Urogenital Diseases, Male
- Prostatic Disease
- Prostatic Neoplasms, Castration-Resistant
- Prostate Cancer
Interventions
- Drug: Gedatolisib
- Drug: Darolutamide — also filed as NUBEQA
Primary outcomes
what the primary-completion date above is the date OFPhase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)
measured Cycle 1, Day 1 to end of safety follow up (each cycle is 28 days and safety follow up will continue until 30 days after last dose of study medication)
Phase 1: Identification of the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPC
measured Through Phase I completion, an average of 1 year.
Phase 2: Assessment of the antitumor activity of gedatolisib in combination with darolutamide in each arm as demonstrated by radiographic progression-free survival (rPFS) by arm
measured 6 months
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