NCT06190899 Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
| NCT ID | NCT06190899 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Celcuity Inc |
| Condition | mCRPC (Metastatic Castration-resistant Prostate Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2028-01 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria 1. Adult males ≥18 years of age 2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \<10% neuroendocrine type cells 3. Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy) 4. Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy. Measurable and non-measurable disease are allowed, but metastases visible only on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) will not be allowed for eligibility purposes. 5. Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one
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