Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
ReDiscover-2
A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor
1 other identifier
interventional
540
23 countries
212
Brief Summary
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2025
Longer than P75 for phase_3
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 21, 2025
CompletedStudy Start
First participant enrolled
August 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
August 5, 2026
July 1, 2026
2.7 years
May 8, 2025
August 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)
The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months
Secondary Outcomes (10)
Overall Survival (OS) within the overall and kinase populations
The time from randomization to the date of death by any cause, up to approximately 77 months
PFS by Investigator within the overall and kinase populations
The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months
Objective Response Rate (ORR) within the overall and kinase populations
Up to approximately 77 months
Duration of Response (DOR) within the overall and kinase populations
Up to approximately 77 months
Clinical Benefit Rate (CBR) within the overall and kinase populations
Up to approximately 77 months
- +5 more secondary outcomes
Study Arms (2)
Zovegalisib + fulvestrant
EXPERIMENTALZovegalisib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer
capivasertib + fulvestrant
ACTIVE COMPARATORcapivasertib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer
Interventions
400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle
500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)
400 mg orally BID administered daily on a 28-day treatment cycle
Eligibility Criteria
You may qualify if:
- Patient has ECOG performance status of 0-1
- One or more known primary oncogenic PIK3CA mutation(s)
- Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 2 weeks prior to randomization and must be willing to continue on it for the duration of the study.
- Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent
- Measurable disease per RECIST v1.1 or evaluable bone-only disease.
- Must have radiological evidence of progression on or after previous treatment for HR+/HER2- ABC with:
- At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting
- Only 1 prior line of CDK4/6 inhibitor therapy in one of the following settings:
- CDK4/6 inhibitor + ET in the ABC setting
- CDK4/6 inhibitor therapy in the adjuvant setting if progression occurred during or within 12 months of completion of adjuvant CDK4/6 inhibitor with ET
- Patients who progressed during or within 12 months of completion of adjuvant CDK4/6 inhibitor and after receiving CDK4/6 inhibitor therapy in the advanced setting are considered to have had \>1 prior line of CDK4/6 inhibitor and are not eligible
You may not qualify if:
- Prior treatment with any of the following:
- CDK2 inhibitors. Prior treatment with other investigational CDK inhibitors could be permitted upon discussion and approval from the Sponsor
- PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway
- Immunotherapy
- Antibody drug conjugates
- Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL (7.8 mmol/L), or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol/mol).
- Clinically significant, uncontrolled cardiovascular disease
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Known active uncontrolled or symptomatic CNS metastases associated with progressive neurological symptoms or requiring ongoing corticosteroids or anticonvulsants for symptomatic control
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- History of hypersensitivity to fulvestrant or drugs in a similar class as fulvestrant, zovegalisib, or capivasertib, including their excipients
- Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (222)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford Women's Cancer Center
Palo Alto, California, 94304, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California San Diego Moores Cancer Center
San Diego, California, 92037, United States
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, 80504, United States
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, 06510, United States
Medical Oncology Hematology Consultants, P.A.
Newark, Delaware, 19713, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
AdventHealth
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists-South
Fort Myers, Florida, 33901, United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32909, United States
Atlanta Cancer Care - Northside Hospital
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60607, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
Community Health Network, Inc
Indianapolis, Indiana, 46250, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Profound Research LLC
Royal Oak, Michigan, 48073, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39213, United States
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, 63108, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Renown Health Medical Oncology
Reno, Nevada, 89502, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, 97210, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Texas Oncology Central/South
Austin, Texas, 78731, United States
Texas Oncology DFW
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Hospital Cancer Center
Houston, Texas, 77030, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Baylor Scott and White Medical Center
Temple, Texas, 76508, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
University of Wisconsin Carbone Cancer Center- University Hospital
Madison, Wisconsin, 53792, United States
Organización Médica de Investigación (OMI)
Buenos Aires, 1015, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, 1280, Argentina
Centro Medico Dr. Doreski- Fundacion Respirar
Buenos Aires, 1426, Argentina
Instituto de Investigaciones Clinicas de Cordoba
Córdoba, 5000, Argentina
Breast clinica de la mama
La Plata, 1900, Argentina
Hospital Provincial del Centenario
Rosario, 2002, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma, R8500ACE, Argentina
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Lake Macquarie Hospital
Gateshead, New South Wales, 2290, Australia
Mater Hospital Sydney
North Sydney, New South Wales, 2060, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000, Australia
Bayside Health (Alfred)
Melbourne, Victoria, 3004, Australia
Sunshine Hospital
Saint Albans, Victoria, 3021, Australia
Ballarat Oncology & Haematology Clinical Research Fund
Wendouree, Victoria, 3355, Australia
Medical University of Graz
Graz, 8036, Austria
Ordensklinikum Linz GmbH
Linz, 4010, Austria
LKH Feldkirch, Interne E am LKH Rankweil
Rankweil, 6830, Austria
Institut Jules Bordet
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier de l'Ardenne
Libramont, 6800, Belgium
Clinique CHC Mont Legia
Liège, 4000, Belgium
CHU-UCL Namur, Site Sainte-Elisabeth
Namur, 5000, Belgium
Vitaz
Sint-Niklaas, 9100, Belgium
CHR de Verviers site Tourelle
Verviers, 4800, Belgium
CEMEC CTO (CPAM - Centro de Pesquisas da Amazônia)
Belém, 66073-005, Brazil
Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro)
Belo Horizonte, 30360-680, Brazil
Instituto do Câncer do Ceará
Fortaleza, 60430-235, Brazil
Hospital de Cancer Araujo Jorge/ Associacao de Combate ao Cancer em Goias
Goiânia, 74605-070, Brazil
Oncoclinicas Natal- Centro de Pesquisa Oncology Natal
Natal, 59020-505, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Centro Gaúcho Integrado - Hospital Mae de Deus
Porto Alegre, 90110-270, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre, 90560-032, Brazil
Uniao Brasileira de Educacao e Assistencia/ Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, 22250-905, Brazil
Instituto de Educação Pesquisa e Gestão em Saúde
Rio de Janeiro, 22775-001, Brazil
Nucleo de Oncologia da Bahia S.A.
Salvador, 40170-110, Brazil
Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do Sul
São Caetano do Sul, 09541-270, Brazil
Sociedade Beneficente de Senhora Hospital Sírio-Libanês
São Paulo, 01308-050, Brazil
Clinica Onco Star
São Paulo, 04543-000, Brazil
MHAT "Dr. Tota Venkova", AD
Gabrovo, 5300, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD
Sofia, 1407, Bulgaria
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H8L6, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, 741 01, Czechia
Fakultni Nemocnice Olomouc
Olomouc, 779 00, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Zealand University Hospital
Næstved, 4700, Denmark
Sønderborg Sygehus
Sønderborg, 6400, Denmark
L'Institut de Cancérologie de l'Ouest (ICO) - Angers
Angers, 49055, France
CHU Besancon
Besançon, 25030, France
Hopital Avicenne
Bobigny, 93000, France
Institut Bergonie
Bordeaux, 33076, France
Centre François Baclesse
Caen, 14000, France
Centre Leon Berard
Lyon, 69008, France
Hôpital Privé Jean Mermoz
Lyon, 69008, France
Hôpital de la Timone
Marseille, 13005, France
Centre de Cancérologie du Grand Montpellier
Montpellier, 34070, France
Centre Antoine Lacassagne
Nice, 06100, France
Institut Curie
Paris, 75005, France
Hôpital Saint Louis - SENOPOLE
Paris, 75010, France
Hôpital Privé des Côtes d'Armor
Plérin, 22190, France
Institut de Cancerologie de l'Ouest ICO
Saint-Herblain, 44800, France
Hopital du Leman
Thonon-les-Bains, 74200, France
Institut Claudius Regaud
Toulouse, 31300, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
UNEOS - Hopital Robert Schuman
Vantoux, 57000, France
Institut Gustave Roussy
Villejuif, 94800, France
MVZ Klinikum Aschaffenburg
Aschaffenburg, 63768, Germany
Marienhospital Bottrop gGmbH
Bottrop, 46236, Germany
Universitätsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Studienzentrale für das MVZ Eggenfelden GbR
Eggenfelden, 84307, Germany
Praxis fuer Interdisziplinaere Onkologie und Haematologie
Freiburg im Breisgau, 79110, Germany
Helios Klinikum Krefeld
Krefeld, 47805, Germany
Universitaetsmedizin Mannheim
Mannheim, 68167, Germany
Anticancer Hospital "Agios Savvas"
Athens, 115 22, Greece
University General Hospital of Athens "Attikon"
Athens, 124 62, Greece
Iaso Hospital
Athens, 151 21, Greece
General University Hospital of Crete
Heraklion, 715 00, Greece
University Hospital of Larissa
Larissa, 41110, Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, 570 01, Greece
Hong Kong United Oncology Centre
Hong Kong, HGK, Hong Kong
Queen Mary Hospital
Hong Kong, HGK, Hong Kong
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123, Italy
IRCCS Candiolo
Candiolo, 10060, Italy
AOU Ferrara, Arcispedale Sant'Anna
Cona, 44124, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Azienda USl Toscana Nord Ovest SC Oncologia Medica Ospedale Civile Livorno
Livorno, 57124, Italy
IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori"
Meldola, 47014, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Hospital San Giuseppe
Milan, 50053, Italy
Humanitas Istituto Clinico Catanese
Misterbianco, 95045, Italy
Irccs Iov
Padova, 35128, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
Azienda Ospedaliera S.Maria - Terni
Terni, 05100, Italy
Maastricht University Medical Center
Maastricht, 6229, Netherlands
Radboud UMC
Nijmegen, 6525, Netherlands
Zuyderland Medisch Centrum - Heerlen
Sittard, 6419, Netherlands
Haga Ziekenhuis
The Hague, 2545, Netherlands
Przychodnia Lekarska KOMED
Konin, 62-500, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 60-355, Poland
Mruk-Med Sp. z o.o
Rzeszów, 35-234, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - w Warszawie - Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej
Warsaw, 02-781, Poland
Hospital da Luz
Lisbon, 1500-650, Portugal
Hospital CUF Descobertas
Lisbon, 1998-018, Portugal
Unidade Local de Saude de Loures Odivelas E.P.E. Hospital Beatriz Angelo
Loures, 2674-514, Portugal
Raffles Hospital
Singapore, 188770, Singapore
Curie Oncology (Farrer)
Singapore, 217562, Singapore
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Seoul National University Bundang Hospital
Seoul, 13620, South Korea
Hospital Universitario de Badajoz
Badajoz, 06006, Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital General de Catalunya
Barcelona, 08195, Spain
Institut Català d'Oncologia de L'Hospìtalet (ICO l'Hospitalet)
Barcelona, 08908, Spain
Hospital Provincial de Castellon
Castellon, 12002, Spain
Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, 30120, Spain
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitaro de Jaen
Jaén, 23007, Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
Hospital Beata Maria Ana/IOB Madrid
Madrid, 28007, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
Hospital Universitario Son Espases
Palma de Mallorca, 07120, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
Instituto Valenciano de Oncologia (IVO)
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Tumor Zentrum Aarau
Aarau, 5000, Switzerland
University Hospital of Basel
Basel, 4031, Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 23561, Taiwan
Taichung Veterans General Hospital
Taichung, 407219, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG, United Kingdom
St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
University College London Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2025
First Posted
May 21, 2025
Study Start
August 26, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
December 31, 2031
Last Updated
August 5, 2026
Record last verified: 2026-07