Tests gedatolisib with darolutamide in advanced prostate cancer
Tests gedatolisib with darolutamide in men with prostate cancer that stopped responding to hormones.
Plain-language title generated from the registry record
Registry title: Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
Key facts
- Where
- Clermont-Ferrand, Marseille, Nice Cedex 2, and Villejuif, FranceSee the 4 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult men with prostate cancer that has spread and no longer responds to hormone-lowering treatment, and that grew during treatment with one next-generation hormone-blocking drug.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer (adenocarcinoma) that has spread to other parts of the body and keeps growing despite hormone-lowering treatment or surgical castration (mCRPC). Growth is shown by rising PSA, growing soft-tissue tumours, or new bone lesions. No small cell component and fewer than 10% neuroendocrine-type cells. ECOG performance status 1 or lower.
- Earlier treatment
- Disease must have grown during treatment with one next-generation androgen receptor signaling inhibitor (for example abiraterone, enzalutamide, apalutamide, darolutamide), finished at least 4 weeks before the first study dose. Hormone-lowering treatment (LHRH analog) must continue unless the person has had both testicles removed. Cannot have had a PI3K, AKT or mTOR inhibitor, or chemotherapy or radiopharmaceutical treatment for mCRPC.
- Biomarker or test result
- PSA of at least 1.0 ng/mL, with at least 2 rising PSA levels taken at least 1 week apart, is needed if progression is shown by PSA.
Main reasons for not taking part
- Another cancer in the past, except treated non-melanoma skin cancer or tumours with no disease for 3 years or more
- Prior PI3K, AKT or mTOR inhibitor treatment
- Uncontrolled type 1 or type 2 diabetes
- Brain or leptomeningeal metastases that are untreated or active
- Cannot swallow tablets or capsules, or has a gut disease that stops oral medicine from being absorbed
Read by machine on 12 November 2026.
Where in France
- Centre Jean PerrinClermont-Ferrand, FranceTaking people
- Institut Paoli-CalmettesMarseille, FranceTaking people
- Centre Antoine LacassagneNice Cedex 2, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Celcuity Inc
- Trial code
- NCT06190899EU 2023-505898-32-00
- Record updated
- 13 April 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Adult males ≥18 years of age; Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with <10% neuroendocrine type cells; Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy); 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; 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 of the following criteria:; 5.1. Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. A minimum PSA of 1.0 ng/mL is required for study entry; 5.2. Soft-tissue progression defined as an increase ≥20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 5.3. Progression of bone disease (measurable disease) or 2 or more new bone lesions by bone scan; Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy; Eastern Cooperative Oncology Group (ECOG) performance status score ≤1; Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide); Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug; At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and/or radiation therapy, and resolution of all toxicities related to prior therapies or surgical procedures to baseline (except alopecia, Grade 1 peripheral neuropathy); Adequate bone marrow, hepatic, renal and coagulation function.
Exclusion: Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor; Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide); Known and untreated, or active, brain or leptomeningeal metastases. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to randomization 10. History of clinically significant cardiovascular abnormalities 11. Gastrointestinal tract disease resulting in an inability to absorb oral medication as well as history of inflammatory bowel disease 12. Unable to swallow oral medication tablets/capsules; Subjects with uncontrolled type 1 or type 2 diabetes; History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥3 years; Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells.