Celcuity Inc.
- Address
- 2800 Campus Drive Suite 140
Sponsor Overview
Specializations
Prostate Cancer
Clinical research in metastatic castration-resistant prostate cancer focuses on treatment resistance and disease control in advanced prostate cancer.
- Metastatic castration-resistant prostate cancer
- Advanced prostate malignancy
- Androgen receptor pathway targeting
The sponsor’s activity is centered on combination treatment strategies for men with progressive disease after hormonal therapy, with attention to outcomes linked to radiographic progression-free survival.
Targeted Oncology Combinations
Research includes the pairing of gedatolisib with darolutamide, reflecting interest in combining pathway inhibition with established androgen receptor-directed therapy.
- PI3K/AKT/mTOR pathway inhibition
- Androgen receptor inhibition
- Combination anti-cancer therapy
This area addresses therapeutic resistance in mCRPC through dual-mechanism treatment approaches.
Oncology Safety and Tolerability
Clinical interest also includes the safety and tolerability of investigational oncology combinations in patients with advanced solid tumors.
- Adverse event monitoring
- Tolerability assessment
- Combination regimen safety
These studies support evaluation of treatment suitability in a population with limited options after standard hormonal therapy.
Late-Stage Disease Control
Research is directed toward controlling tumor progression in advanced prostate cancer, with emphasis on measurable disease outcomes in the metastatic setting.
- Radiographic progression-free survival
- Antitumor activity
- Metastatic disease management
The sponsor’s trial activity is concentrated on clinical endpoints relevant to patients with castration-resistant disease.
Sponsored Trials
| Trial Name | Country | Status |
|---|---|---|
| A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination with Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) |  France Spain | Recruiting |
| Phase 3 Randomized Study of Gedatolisib Combination Therapy versus Standard Endocrine Therapy in HR‑Positive, HER2‑Negative Advanced Breast Cancer Post‑CDK4/6 Inhibitor |  Austria Belgium Bulgaria Czechia France Germany Greece Hungary Italy Poland Romania Spain | Not Recruiting |
Data & Insights
This sponsor works with 6 molecules, of which 1 is not being studied by other sponsors.
This sponsor has worked with 90 sites across their trial portfolio.
Therapeutic Focus
- 1.Hormonal diseases1 trial89 other sponsors
- 2.Male Urogenital Diseases1 trial111 other sponsors
Partnered Research Centres
90 centres- Address
- Vassilissis Sofias Avenue 80, 115 28 Athens
- Address
- President Kennedylaan 4, 8500 Kortrijk
- Address
- 264 Rue Saint Pierre, 13005 Marseille
- Address
- Pylea, Asklipiou 10, 546 39 Thessaloniki
- Address
- Largo Del Pozzo 71, 41124 Modena
- Address
- Viale Antonio Gramsci 14, 43126 Parma
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