Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New targeted cancer drug STX-478 enters human trials

NCT ID NCT05768139

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 880 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort) * Has a new or recent tumor biopsy (collected at screening, if feasible) or will provide an adequate tissue sample prior to screening * Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types) * Is ≥18 years of age at the time of signing the ICF * Has an ECOG performance status score of 0 or 1 at screening * Has adequate organ function as defined per protocol Key Exclusion Criteria: * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied * Has symptomatic brain or spinal metastases * Has an established diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8% and/or FBG ≥140 mg/dL \[7.7 mmol/L\] and/or requiring or required insulin). * Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances * Has had treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to the initiation of study treatment up to a maximum washout period of 28 days. Endocrine therapy does not require a washout period if the patient is enrolling in a cohort with the same combination endocrine therapy. * Has toxicities from previous anticancer therapies that have not resolved to baseline levels or CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy. * Has had radiotherapy within 14 days before the initiation of study treatment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    61 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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.