Clinical trials

3

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Participants needed: 1,180
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Celcuity IncUpdated: May 18, 2026Locations: 203
Eligibility criteria

Histologically or cytologically confirmed diagnosis of metastatic or locally adv... [+11]

Concurrent malignancies other than adequately treated non-melanoma skin cancer.... [+7]

Status: Recruiting

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.

Participants needed: 54
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: Celcuity IncUpdated: Apr 13, 2026Locations: 13
Eligibility criteria

Adult males ≥18 years of age [+9]

History of malignancies other than adequately treated non-melanoma skin cancer o... [+4]

Status: Available

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Trial details
Age: 18+Biological sex: FemaleType: Expanded AccessSponsor: Celcuity IncUpdated: Mar 21, 2025Locations: 5
Eligibility criteria

Currently enrolled in the B2151009 clinical study and benefiting from treatment... [+3]

Permanently discontinued from treatment in Study B2151009, or discontinued from... [+1]