New drug targets Hard-to-Treat cancers with PI3K mutation
NCT ID NCT06239467
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial tests a new drug called OKI-219 in people with advanced solid tumors or breast cancer that have a specific PI3K gene mutation. The drug is designed to block the mutant protein and slow cancer growth. Up to 200 participants will receive OKI-219 alone or combined with other cancer drugs to find the safest dose and see if it works.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
OKI-219 (a targeted drug that blocks a specific mutant protein called PI3KαH1047R)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced cancers that have a specific PI3K mutation, especially breast cancer.
What could go wrong
This is an early Phase 1 trial, so the drug may not be safe or effective. Side effects could be serious, and the benefit is uncertain.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
Contact Email: •••••@•••••
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California Cancer Associates for Research and Excellence
RECRUITINGEncinitas, California, 92024, United States
Contact Email: •••••@•••••
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Centre Antoine Lacassagne
RECRUITINGNice, 06189, France
Contact Email: •••••@•••••
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Centre Leon Berard
RECRUITINGLyon, 69008, France
Contact Email: •••••@•••••
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Centre Oscar Lambret
RECRUITINGLille, 59020, France
Contact Email: •••••@•••••
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Centre de Lutte Contre le Cancer CLCC - Centre Georges Francois Leclerc (CGFL)
RECRUITINGDijon, 21079, France
Contact Email: •••••@•••••
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Comprehensive Cancer Centers of Nevada
RECRUITINGLas Vegas, Nevada, 89169, United States
Contact Email: •••••@•••••
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
Contact Email: •••••@•••••
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GZA Hopsitals Campus Sint-Augustinus
RECRUITINGWilrijk, 2610, Belgium
Contact Email: •••••@•••••
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Gachon University Gil Medical Center
RECRUITINGIncheon, 21565, South Korea
Contact Email: •••••@•••••
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Hoag - Huntington Beach
RECRUITINGNewport Beach, California, 92663, United States
Contact Email: •••••@•••••
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Hopital Lyon Sud
RECRUITINGPierre-Bénite, 69310, France
Contact Email: •••••@•••••
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Hospital Beata Maria Ana
RECRUITINGMadrid, 28007, Spain
Contact Email: •••••@•••••
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, 28041, Spain
Contact Email: •••••@•••••
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Institut Gustave Roussy
RECRUITINGVillejuif, 94805, France
Contact Email: •••••@•••••
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Institut Jules Bordet
RECRUITINGAnderlecht, 1070, Belgium
Contact Email: •••••@•••••
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Istituto Clinico Humanitas
RECRUITINGRozzano, 20089, Italy
Contact Email: •••••@•••••
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Karmanos Cancer Insitute
WITHDRAWNDetroit, Michigan, 48201, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
Contact Email: •••••@•••••
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NEXT Oncology Phase I Unit / IOB- Hospital Quironsalud Barcelona
RECRUITINGBarcelona, 08023, Spain
Contact Email: •••••@•••••
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NEXT Oncology Virginia
RECRUITINGFairfax, Virginia, 22031, United States
Contact Email: •••••@•••••
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Ospedale San Gerardo-ASST Monza
RECRUITINGMonza, 20900, Italy
Contact Email: •••••@•••••
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Ospedale San Raffaele
RECRUITINGMilan, 20132, Italy
Contact Email: •••••@•••••
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Regents of the University of Colorado
RECRUITINGAurora, Colorado, 80045, United States
Contact Email: •••••@•••••
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SCRI Oncology Partners - Nashville
RECRUITINGNashville, Tennessee, 37203, United States
Contact Email: •••••@•••••
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START - Madrid
RECRUITINGMadrid, 28050, Spain
Contact Email: •••••@•••••
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
Contact Email: •••••@•••••
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Sarah Cannon Research Institute at HealthONE
RECRUITINGDenver, Colorado, 80218, United States
Contact Email: •••••@•••••
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
Contact Email: •••••@•••••
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Severance Hospital
RECRUITINGSeoul, 03722, South Korea
Contact Email: •••••@•••••
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Stony Brook University
RECRUITINGStony Brook, New York, 11794, United States
Contact Email: •••••@•••••
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UCLA Jonsson Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90024, United States
Contact Email: •••••@•••••
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UZ Leuven - Campus Gasthuisberg
RECRUITINGLeuven, 3000, Belgium
Contact Email: •••••@•••••
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University of California San Diego UCSD
RECRUITINGLa Jolla, California, 92093, United States
Contact Email: •••••@•••••