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mCRPC (Metastatic Castration-resistant Prostate Cancer)Phase 1/2NCT06190899

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

A Phase 1/2 study testing Gedatolisib and Darolutamide in people with mCRPC (Metastatic Castration-resistant Prostate Cancer) and Genital Diseases, Male, run by Celcuity Inc at 13 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Gedatolisib and Darolutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
13 sitesin 4 countries
Study dates
1 Jan 2024to Jan 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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

Who cannot join

  • 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
  • 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).
  • Subjects with uncontrolled type 1 or type 2 diabetes
  • 9. 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

Trial locations and contacts

13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Genelle Brower, RN contact

844-310-3900

gbrower@celcuity.com

13 sites in 4 countries

Spain5 sites, 5 recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Recruiting

  • Institut Catala d'Oncologia

    Barcelona, 08908

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

    Not yet recruiting

  • Hospital 12 de Octubre

    Madrid, 28045

    Recruiting

  • Instituto Valenciano de Oncología

    Valencia, 46009

    Not yet recruiting

Other trials in Spain

France4 sites, 4 recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Not yet recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice, 06100

    Not yet recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Not yet recruiting

Other trials in France

United Kingdom3 sites, 3 recruiting

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita

    Cambridge, CB20QQ

    Not yet recruiting

  • University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

    Southampton, SO16 6YD

    Not yet recruiting

  • Royal Marsden NHS Foundation Trust

    Sutton, SM25PT

    Recruiting

Other trials in United Kingdom

United States1 site, 1 recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and pharmacokinetics of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with darolutamide, a next-generation androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer following progression on a next-generation androgen receptor inhibitor. The aim of the Phase 1 portion of the study is to evaluate dose limiting toxicities and to determine the recommended Phase 2 dose. The aim of the Phase 2 portion of the study is to further assess the safety and preliminary efficacy of the drug combination.

Being tested
Gedatolisib, Darolutamide
Keywords
Gedatolisib, PI3K, Protein Kinase Inhibitors, mCRPC (metastatic castration-resistant prostate cancer), Darolutamide, Prostate Cancer, Prostatic Neoplasms, Castration-Resistant, Prostatic Disease, Urogenital Diseases, Male, Genital Diseases, Male
Medical subject headings
Genital Diseases, Male, Male Urogenital Diseases, Prostatic Diseases, Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GedatolisibDrug

    Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.

  • DarolutamideDrug

    Also called NUBEQA

    Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer.

Study groups in NCT06190899
Study groupRoleWhat they receive
Phase 1 Arm 1ExperimentalArm 1 - 120 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
Receives: Drug: Gedatolisib; Drug: Darolutamide
Phase 1 Arm 2ExperimentalArm 2 - 180 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
Receives: Drug: Gedatolisib; Drug: Darolutamide
Phase 2ExperimentalThe recommended Phase 2 dose (RP2D) of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
Receives: Drug: Gedatolisib; Drug: Darolutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)

    Type, incidence, severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities

    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)

  2. Phase 1: Identification of the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPC

    Incidence of dose-limiting toxicities (DLTs) and AEs graded according to NCI CTCAE v5.0

    Measured: Through Phase I completion, an average of 1 year.

  3. 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

    Radiographic progression-free survival rate at 6 months as measured by the Kaplan-Meier (K-M) method and assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria

    Measured: 6 months

Secondary outcomes (1)

  1. Assessment of the preliminary efficacy of gedatolisib in combination with darolutamide by arm

    Radiographic progression-free survival rates at 9 and 12 months and overall rPFS Overall Survival (OS) rate at 18 and 24 months

    Measured: 9 and 12 months post Cycle 1 Day 1 (each cycle is 28 days); 18 and 24 months post Cycle 1 Day 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start1 Jan 2024
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model 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. The study is comprised of two phases: * Phase 1 Dose Finding (2 Parts) o Part 1: DLT evaluation and determination of tolerated doses * Part 2: Determination of RP2D * Phase 2 Dose Expansion
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06190899
Sponsor's protocol ID
CELC-G-201
Status last verified
Apr 2026
First submitted
13 Dec 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gedatolisib and Darolutamide in people with mCRPC (Metastatic Castration-resistant Prostate Cancer) and Genital Diseases, Male, run by Celcuity Inc at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain, France, United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Genelle Brower, RN (844-310-3900, gbrower@celcuity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06190899.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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