A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Celgene (industry)

Phase: 3

Start date: March 13, 2025

Planned enrollment: 960

Trial ID: NCT06764485
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: BMS-986365 (Gridegalutamide)

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Goal: Compare the efficacy and safety of BMS-986365 with investigator-selected therapy in metastatic castration-resistant prostate cancer (mCRPC).

Patients: Patients with metastatic prostate adenocarcinoma who have previously received an androgen receptor pathway inhibitor and have no or mild cancer-related symptoms (BPI-SF pain score below 4). Patients with brain or liver metastases, clinically significant cardiac disease, or a superscan on bone scintigraphy are excluded.

Design: Randomized, open-label, adaptive, two-part trial. Part 1 assigns patients 1:1:1 to either of two BMS-986365 doses or investigator's choice; Part 2 assigns patients 1:1 to the selected BMS-986365 dose or investigator's choice.

Treatments: BMS-986365 (gridegalutamide) is an investigational oral androgen receptor–targeting drug that promotes cereblon-dependent receptor degradation and blocks signaling through remaining receptors. In a noncomparative phase 1 dose-expansion cohort, 19 of 60 patients (32%) had a PSA decline of at least 50%, and median radiographic progression-free survival was 6.3 months; these findings do not establish a benefit over standard therapy. Investigator's choice is docetaxel with prednisone or prednisolone, or a second androgen receptor pathway inhibitor—abiraterone with prednisone or prednisolone, or enzalutamide.

Outcomes: The primary endpoint is radiographic progression-free survival by blinded independent central review using RECIST 1.1 and PCWG3 criteria. Secondary measures include overall survival, response and PSA response, progression and symptom-related endpoints, time to subsequent systemic therapy, patient-reported quality of life and pain, and safety, including adverse events, laboratory abnormalities, and ECG findings. Follow-up for most outcomes extends up to 4 years.

Burden on patient: Estimated moderate burden: participation entails serial imaging, laboratory tests, ECGs, pain and quality-of-life questionnaires, and follow-up visits over a potentially long period. ECG monitoring is particularly relevant given QT prolongation and bradycardia observed in the phase 1 study. Patients assigned docetaxel will also need infusion visits. The visit frequency and any additional research-only procedures are not specified.

Last updated: Sep 2026

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Buenos Aires, C1419AHN, Argentina

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Hospital Privado Universitario de Córdoba

Córdoba, 5016, Argentina

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Hospital Británico de Buenos Aires

CABA, Buenos Aires, CP1280AEB, Argentina

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Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

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Córdoba, Córdoba Province, X5004BAL, Argentina

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Clinica Viedma S. A

Viedma, R, R8500ACE, Argentina

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Campbelltown, New South Wales, 2560, Australia

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Macquarie University

Macquarie University, New South Wales, 2109, Australia

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Port Macquarie - Mid North Coast Cancer Institute

Port Macquarie, New South Wales, 2444, Australia

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St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

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Wahroonga, New South Wales, 2076, Australia

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Greenslopes Private Hospital - Gallipoli Medical Research Foundation

Greenslopes, Queensland, 4120, Australia

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Tasman Oncology Research

Southport, Queensland, 4215, Australia

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ICON Cancer Centre - Kurralta Park

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Lyell McEwin Hospital

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Vienna, 1090, Austria

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Salzburg, 5020, Austria

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Linz, Upper Austria, 4020, Austria

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Belo Horizonte, Minas Gerais, 30110-022, Brazil

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Natal, Rio Grande do Norte, 59075-740, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

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São Paulo, São Paulo, 01509-010, Brazil

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São Paulo, São Paulo, 01308-060, Brazil

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Linhai, Zhejiang, 317000, China

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Hangzhou, Zhejiang, 310014, China

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Aalborg, North Denmark, 9000, Denmark

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Nice, Alpes-Maritimes, 06189, France

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Strasbourg, Alsace, 67033, France

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Oncopole Claudius Regaud

Toulouse, Haute-Garonne, 31059, France

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Vandœuvre-lès-Nancy, Lorraine, 54519, France

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Pierre-Bénite, Rhône, 69310, France

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Le Mans, Sarthe, 72000, France

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Herne, 44625, Germany

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Essen, 45122, Germany

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München, Bavaria, 81675, Germany

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Dublin, D9, Ireland

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Terni, 05100, Italy

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Foggia, 71100, Italy

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Arezzo, 52100, Italy

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Milan, Lombardy, 20133, Italy

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Orbassano, Piedmont, 10043, Italy

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Rome, Roma, 00144, Italy

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Padova, Veneto, 35128, Italy

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Bydgoszcz, 85796, Poland

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Katowice, 40-519, Poland

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Gdansk, Pomeranian Voivodeship, 80-219, Poland

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Bytom, Silesian Voivodeship, 41-902, Poland

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Iași, 700483, Romania

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Ploieşti, 100337, Romania

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Cluj-Napoca, 400015, Romania

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Craiova, Dolj, 200542, Romania

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Prešov, Presov, 080 01, Slovakia

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Goyang-si, Kyǒnggi-do, 10408, South Korea

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Seongnam, Kyǒnggi-do, 13620, South Korea

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Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

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Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

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Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

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Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

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Madrid, 28040, Spain

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Badajoz, 06006, Spain

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Valencia, 46026, Spain

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Seville, 41013, Spain

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Seville, 41009, Spain

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Burgos, 09006, Spain

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Granada, 18008, Spain

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Córdoba, Andalusia, 14004, Spain

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Sabadell, Barcelona [Barcelona], 08208, Spain

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Barcelona, Barcelona [Barcelona], 08035, Spain

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Barakaldo, Bizkaia, 48903, Spain

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Barcelona, Catalunya [Cataluña], 08041, Spain

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Lugo, Lugo [Lugo], 27003, Spain

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Madrid, Madrid, Comunidad de, 28009, Spain

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Madrid, Madrid, Comunidad de, 28041, Spain

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Madrid, Madrid, Comunidad de, 28046, Spain

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Majadahonda, Madrid, Comunidad de, 28222, Spain

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Madrid, Madrid, Comunidad de, 28034, Spain

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Pamplona, Navarre, 31009, Spain

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Complexo Hospitalario Universitario de Ourense

Ourense, Ourense [Orense], 32005, Spain

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Skånes Universitetssjukhus Lund

Lund, Skåne Län [se-12], 22185, Sweden

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Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01], 171 64, Sweden

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Akademiska sjukhuset

Uppsala, Uppsala Län [se-03], 751 85, Sweden

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Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

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Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

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China Medical University Hospital

Taichung, 404332, Taiwan

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National Taiwan University Hospital

Taipei, 10002, Taiwan

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Taipei, 11217, Taiwan

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The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

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Glasgow, Glasgow City, G12 0YN, United Kingdom

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Mount Vernon Hospital

Northwood, Hillingdon, HA6 2RN, United Kingdom

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St Bartholomew's Hospital

London, London, City of, EC1A 7BE, United Kingdom

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London, Sutton, SM2 5PT, United Kingdom

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Central Alabama Research

Birmingham, Alabama, 35209, United States

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Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

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Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

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Los Angeles Cancer Network (LACN)

Anaheim, California, 92801, United States

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Moores Cancer Center

La Jolla, California, 92093, United States

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Pacific Hematology Oncology Associates

San Francisco, California, 94115, United States

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Status: Recruiting

San Francisco VA Health Care System

San Francisco, California, 94121, United States

No email / 415-502-0696

Status: Recruiting

Colorado Clinical Research

Lakewood, Colorado, 80228, United States

No email / 303-885-9828

Status: Recruiting

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218, United States

No email / 303-418-7639

Status: Recruiting

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

No email / 720-848-0300

Status: Recruiting

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

No email / 617-820-3433

Status: Recruiting

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

No email / 412-573-9554

Status: Recruiting

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

No email / 706-353-2990

Status: Recruiting

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

No email / 312-926-2413

Status: Recruiting

The University of Kansas Cancer Center - Westwood

Westwood, Kansas, 66205, United States

No email / 913-588-6029

Status: Recruiting

Wichita Urology Group

Wichita, Kansas, 67226, United States

No email / 316-636-6141

Status: Recruiting

Chesapeake Urology

Baltimore, Maryland, 21204, United States

No email / 443-471-5741

Status: Recruiting

James M Stockman Cancer Institute

Frederick, Maryland, 21702, United States

No email / 301-662-8477

Status: Recruiting

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

No email / 617-820-3433

Status: Recruiting

Thomas Jefferson University, Kennedy Health Alliance

Sewell, New Jersey, 08080, United States

No email / 215-481-2400

Status: Recruiting

New Mexico Oncology Hematology Consultants Ltd.

Albuquerque, New Mexico, 87109, United States

No email / 505-842-8171

Status: Recruiting

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87106, United States

No email / 505-272-4946

Status: Recruiting

Associated Medical Professionals - Urology

Syracuse, New York, 13210, United States

No email / 315-478-4185

Status: Recruiting

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

No email / 212-604-6010

Status: Recruiting

Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

No email / 347-724-5409

Status: Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

No email / 646-422-4379

Status: Recruiting

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

No email / 347-724-5409

Status: Recruiting

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

No email / 716-845-8387

Status: Recruiting

Providence Portland Medical Center

Portland, Oregon, 97213, United States

No email / 503-215-5696

Status: Recruiting

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

No email / 503-215-5696

Status: Recruiting

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

No email / 215-481-2400

Status: Recruiting

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

No email / 215-728-3889

Status: Recruiting

Philadelphia Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

No email / (215)823-5800x206895

Status: Recruiting

Thomas Jefferson University - Clinical Research Institute

Philadelphia, Pennsylvania, 19107, United States

No email / 215-481-2400

Status: Recruiting

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

No email / 843-449-1010

Status: Recruiting

Hollings Cancer Center

Charleston, South Carolina, 29425, United States

No email / 803-413-1355

Status: Recruiting

Tennessee Oncology

Nashville, Tennessee, 37203, United States

No email / 877-836-6662

Status: Recruiting

Texas Oncology - Central/South Texas

Austin, Texas, 78705, United States

No email / 512-427-9400

Status: Recruiting

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / 713-792-5543

Status: Recruiting

Urology Austin, PLLC

Austin, Texas, 78681, United States

No email / 336-512-0813

Status: Recruiting

Intermountain Medical Center

Murray, Utah, 84107, United States

No email / 913-568-7449

Status: Recruiting

University of Virginia Cancer Center

Charlottesville, Virginia, 22903, United States

No email / 434-981-5585

Status: Recruiting

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

No email / 503-885-5411

Status: Recruiting

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

No email / 000-000-0000

Status: Recruiting

Local Institution - 0130

Río Cuarto, Córdoba Province, X5800AEV, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0039

Vitória, Espírito Santo, 29055450, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0168

Beijing, Beijing Municipality, 100005, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0176

Beijing, Beijing Municipality, 100142, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0237

Chongqing, Chongqing Municipality, 400030, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0415

Huizhou, Guangdong, 516001, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0222

Harbin, Heilongjiang, 150081, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0211

Zhengzhou, Henan, 450003, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0279

Zhengzhou, Henan, 450008, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0284

Wuhan, Hubei, 430030, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0216

Changsha, Hunan, 410008, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0217

Changsha, Hunan, 410013, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0228

Nanjing, Jiangsu, 210009, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0198

Xi'an, Shaanxi, 710061, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0212

Shanghai, Shanghai Municipality, 200032, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0308

Shanghai, Shanghai Municipality, 200080, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0205

Taiyuan, Shanxi, 030001, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0181

Hangzhou, Zhejiang, 310003, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0223

Wenzhou, Zhejiang, 325000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0280

Hangzhou, Zhejiang, 310022, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0418

Prague, Praha 4, 14059, Czechia

No email / No phone

Status: Not yet recruiting

Local Institution - 0432

Dijon, Côte-d'Or, 21079, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0431

Saint-Grégoire, Ille-et-Vilaine, 35760, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0454

Biedenkopf, 35216, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0456

Duisburg, 47169, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0455

Bergisch Gladbach, North Rhine-Westphalia, 51465, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0404

Thiruvananthapuram, Kerala, 695011, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0401

Navi Mumbai, Maharashtra, 410210, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0400

New Delhi, National Capital Territory of Delhi, 110085, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0402

New Delhi, National Capital Territory of Delhi, 110029, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0405

Kolkata, West Bengal, 700156, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0424

Catania, 95126, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0425

Milan, 20132, Italy

No email / No phone

Status: Not yet recruiting

Local Institution - 0434

Kashiwa, 277-8577, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0439

Fukuoka, 812-8582, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0442

Osaka, 541-8567, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0449

Kobe, 650-0017, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0452

Kumamoto, 860-0008, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0451

Nagoya, Aichi-ken, 466-8560, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0436

Sakura, Chiba, 285-8741, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0441

Matsuyama, Ehime, 791-0280, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0435

Sapporo, Hokkaido, 060-8543, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0446

Sapporo, Hokkaido, 0608648, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0443

Kita-Gun, Kagawa-ken, 7610793, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0444

Kamakura, Kanagawa, 247-8533, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0448

Yokohama, Kanagawa, 232-0024, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0437

Suita, Osaka, 565-0871, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0438

Shinjuku-ku, Tokyo, 1608582, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0440

Koto-ku, Tokyo, 1358550, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0445

Bunkyo-ku, Tokyo, 113-8603, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0447

Toyama, Toyama, 9300194, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0450

Ube, Yamaguchi, 755-8505, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0201

Bratislava, 83101, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0275

Banská Bystrica, 97517, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0200

Martin, Žilina Region, 036 01, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0327

Málaga, 29016, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0314

Santander, Cantabria, 39008, Spain

No email / No phone

Status: Not yet recruiting

Local Institution - 0337

Istanbul, 34295, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0338

Ankara, 06620, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0339

Ankara, 06010, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0340

Adana, 01370, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0341

Ankara, 06800, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0342

Istanbul, 34722, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0085

New York, New York, 10032, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0056

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0220

Houston, Texas, 77030, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0078

Seattle, Washington, 98109, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0215

Shanghai, Shanghai Municipality, 200041, China

No email / No phone

Status: Withdrawn

Local Institution - 0300

Shanghai, Shanghai Municipality, 0, China

No email / No phone

Status: Withdrawn

Local Institution - 0011

Hořovice, Beroun, 268 31, Czechia

No email / No phone

Status: Withdrawn

Local Institution - 0178

Paris, 75014, France

No email / No phone

Status: Withdrawn

Local Institution - 0364

Los Angeles, California, 90048, United States

No email / No phone

Status: Withdrawn

Local Institution - 0104

Minneapolis, Minnesota, 55455, United States

No email / No phone

Status: Withdrawn

Local Institution - 0049

Las Vegas, Nevada, 89148, United States

No email / No phone

Status: Withdrawn

Local Institution - 0433

Allentown, Pennsylvania, 18103, United States

No email / No phone

Status: Withdrawn

Local Institution - 0023

Richmond, Virginia, 23219, United States

No email / No phone

Status: Withdrawn

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