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)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ 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.

‣ 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

Locations
United States
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
Other Locations
France
Centre Jean Perrin
NOT_YET_RECRUITING
Clermont-ferrand
Institut Paoli-Calmettes
NOT_YET_RECRUITING
Marseille
Centre Antoine Lacassagne
NOT_YET_RECRUITING
Nice
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Spain
Hospital Clinic Barcelona
RECRUITING
Barcelona
Institut Catala d'Oncologia
RECRUITING
Barcelona
Hospital 12 de Octubre
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
NOT_YET_RECRUITING
Madrid
Instituto Valenciano de Oncología
NOT_YET_RECRUITING
Valencia
United Kingdom
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita
NOT_YET_RECRUITING
Cambridge
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
Contact Information
Primary
Genelle Brower, RN
gbrower@celcuity.com
844-310-3900
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-11
Participants
Target number of participants: 54
Treatments
Experimental: Phase 1 Arm 1
Arm 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)
Experimental: Phase 1 Arm 2
Arm 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)
Experimental: Phase 2
The 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)
Related Therapeutic Areas
Sponsors
Leads: Celcuity Inc

This content was sourced from clinicaltrials.gov