New targeted cancer drug STX-478 enters human trials

NCT ID NCT05768139

Recruiting now Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests a new drug called STX-478 in people with advanced solid tumors that have a specific genetic change (PI3Kα mutation). The trial has two phases: first, it tests STX-478 alone to find safe doses; then, it combines STX-478 with other cancer drugs like fulvestrant or hormone therapies for breast cancer. About 880 adults with advanced or metastatic tumors will take part. The main goals are to check safety and see if the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: STX-478 (also called Tersolisib), a targeted cancer drug
What this could lead to: If it works, this could offer a new treatment option for people with advanced solid tumors that have a specific genetic mutation (PI3Kα).
What could go wrong: This is a very early (Phase 1/2) trial, so the drug may not work or may have serious side effects. It is also only for people with a specific mutation, so it would not help everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast disorder breast neoplasm cancer endometrium neoplasm Head and Neck Neoplasms hereditary sensory and autonomic neuropathy hormone receptor-positive breast cancer neoplasm Neoplasms by Site ovarian cancer Squamous Cell Carcinoma of Head and Neck Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER SOLID TUMORS, ADULT

Contacts and locations

Locations

Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
RECRUITING

Alessandria, 15100, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
RECRUITING

Pisa, 56126, Italy
Barbara Ann Karmanos Cancer Institute
TERMINATED

Detroit, Michigan, 48201, United States
Centre Antoine-Lacassagne
RECRUITING

Nice, 06189, France
Centre Leon Berard
RECRUITING

Lyon, 69008, France
Centro Ricerche Cliniche di Verona s.r.l.
RECRUITING

Verona, 37134, Italy
Dana-Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Ellison Clinic at Saint John's
RECRUITING

Los Angeles, California, 90064, United States
Erasmus MC
RECRUITING

Rotterdam, 3015GD, Netherlands
Florida Cancer Specialists ORLANDO/DDU
COMPLETED

Lake Mary, Florida, 32746, United States
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING

Monza, 20900, Italy
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING

Roma, 168, Italy
Gustave Roussy
RECRUITING

Villejuif, 94805, France
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Quiron Barcelona
RECRUITING

Barcelona, 08023, Spain
Hospital San Pedro
RECRUITING

Logroño, 26006, Spain
Hospital Universitari Sant Joan de Reus
RECRUITING

Reus, 43204, Spain
Hospital Universitari Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Hospital Universitario Fundación Jiménez Díaz
RECRUITING

Madrid, 28040, Spain
Hospital Universitario HM Sanchinarro
RECRUITING

Madrid, 28050, Spain
Hospital Universitario Quironsalud Madrid
RECRUITING

Pozuelo de Alarcón, 28223, Spain
Hospital Universitario Virgen Macarena
RECRUITING

Seville, 41009, Spain
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
RECRUITING

Bordeaux, 33000, France
Institut Claudius Regaud
RECRUITING

Toulouse, 31059, France
Institut Jules Bordet
RECRUITING

Anderlecht, 1070, Belgium
Institut Paoli-Calmettes
RECRUITING

Marseille, 13009, France
Instituto Oncologico Dr Rosell (IOR)
RECRUITING

Barcelona, 08028, Spain
Istituto Europeo di Oncologia
RECRUITING

Milan, 20141, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
RECRUITING

Milan, 20133, Italy
Kansai Medical University Hospital
RECRUITING

Hirakata, 573-1191, Japan
Kyoto University Hospital
RECRUITING

Kyoto, 606-8507, Japan
Louisiana State University Health Sciences Center
RECRUITING

New Orleans, Louisiana, 70112, United States
MD Anderson Cancer Center
RECRUITING

Madrid, 28033, Spain
Mary Crowley Cancer Research Center
COMPLETED

Dallas, Texas, 75230, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Mater Misericordiae Hospital
RECRUITING

Dublin, Ireland
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States
National Hospital Organization Kyushu Cancer Center
RECRUITING

Fukuoka, 811-1395, Japan
Netherlands Cancer Institute
RECRUITING

Amsterdam, 1066CX, Netherlands
Ospedale Santa Maria delle Croci
RECRUITING

Ravenna, 48121, Italy
Providence Cancer Institute Franz Clinic
RECRUITING

Portland, Oregon, 97213, United States
START Midwest
RECRUITING

Grand Rapids, Michigan, 49546, United States
START Mountain Region
RECRUITING

West Valley City, Utah, 84119, United States
START San Antonio
RECRUITING

San Antonio, Texas, 78229, United States
Saint Luke's Cancer Institute
RECRUITING

Kansas City, Missouri, 64111-3220, United States
Sarah Cannon Research Institute
RECRUITING

Nashville, Tennessee, 37203, United States
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
RECRUITING

Barcelona, 08023, Spain
Spedali Civili di Brescia
NOT_YET_RECRUITING

Brescia, 25123, Italy
Stefanie Spielman Comprehensive Breast Center
RECRUITING

Columbus, Ohio, 43212, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
RECRUITING

Dallas, Texas, 75246-2092, United States
The Cancer Institute Hospital of JFCR
RECRUITING

Kōtō City, 135-8550, Japan
The West Clinic, PLLC dba West Cancer Center
RECRUITING

Germantown, Tennessee, 38138, United States
UCSF Medical Center at Mission Bay
RECRUITING

San Francisco, California, 94143, United States
UH Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
USO-Virginia Cancer Specialists, PC
RECRUITING

Fairfax, Virginia, 22031, United States
UZ Leuven
RECRUITING

Leuven, 3000, Belgium
University of Colorado Cancer Center
RECRUITING

Aurora, Colorado, 80045, United States
University of Iowa
RECRUITING

Iowa City, Iowa, 52242, United States
University of Texas MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
University of Texas Southwestern
RECRUITING

Dallas, Texas, 75390, United States
Universitätsklinikum Erlangen
NOT_YET_RECRUITING

Erlangen, 91054, Germany
Washington University
RECRUITING

St Louis, Missouri, 63110, United States
Winship Cancer Institute, Emory University
RECRUITING

Atlanta, Georgia, 30322, United States
Yale-New Haven Hospital
COMPLETED

New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.