First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 26, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

August 1, 2027

Conditions
Advanced CancerBreast CancerAdvanced Solid TumorsPI3K Gene Mutation
Interventions
DRUG

OKI-219

Oral twice daily

DRUG

Fulvestrant

Intramuscular injection

DRUG

Trastuzumab

Intravenous (IV)

DRUG

Tucatinib

Oral twice daily

DRUG

Atirmociclib

Oral twice daily

DRUG

Ribociclib

Oral once daily continuous for 21-days followed by 7 days off

Trial Locations (34)

1070

RECRUITING

Institut Jules Bordet, Anderlecht

2610

RECRUITING

GZA Hopsitals Campus Sint-Augustinus, Wilrijk

3000

RECRUITING

UZ Leuven - Campus Gasthuisberg, Leuven

11794

RECRUITING

Stony Brook University, Stony Brook

20089

RECRUITING

Istituto Clinico Humanitas, Rozzano

20132

RECRUITING

Ospedale San Raffaele, Milan

20900

RECRUITING

Ospedale San Gerardo-ASST Monza, Monza

21079

RECRUITING

Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL), Dijon

21565

RECRUITING

Gachon University Gil Medical Center, Incheon

22031

RECRUITING

NEXT Oncology Virginia, Fairfax

28007

RECRUITING

Hospital Beata Maria Ana, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28050

RECRUITING

START - Madrid, Madrid

37203

RECRUITING

SCRI Oncology Partners - Nashville, Nashville

48201

WITHDRAWN

Karmanos Cancer Insitute, Detroit

59020

RECRUITING

Centre Oscar Lambret, Lille

69008

RECRUITING

Centre Leon Berard, Lyon

69310

RECRUITING

Hopital Lyon Sud, Pierre-Bénite

80045

RECRUITING

Regents of the University of Colorado, Aurora

80218

RECRUITING

Sarah Cannon Research Institute at HealthONE, Denver

89169

RECRUITING

Comprehensive Cancer Centers of Nevada, Las Vegas

90024

RECRUITING

UCLA Jonsson Comprehensive Cancer Center, Los Angeles

92024

RECRUITING

California Cancer Associates for Research and Excellence, Encinitas

92093

RECRUITING

University of California San Diego UCSD, La Jolla

92663

RECRUITING

Hoag - Huntington Beach, Newport Beach

94805

RECRUITING

Institut Gustave Roussy, Villejuif

98109

RECRUITING

Fred Hutchinson Cancer Center, Seattle

02114

RECRUITING

Massachusetts General Hospital, Boston

06189

RECRUITING

Centre Antoine Lacassagne, Nice

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08023

RECRUITING

NEXT Oncology Phase I Unit / IOB- Hospital Quironsalud Barcelona, Barcelona

All Listed Sponsors
lead

OnKure, Inc.

INDUSTRY