A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PIKASSO-01)

April 17, 2026 updated by: Eli Lilly and Company

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 13176154559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Cancer Research SA
      • East Melbourne, Australia, 3002
        • Peter Maccallum Cancer Institute Erb
      • Sydney, Australia, 2010
        • St Vincent's Hospital
  • Belgium
      • Anderlecht, Belgium, 1070
        • Institut Jules Bordet
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • Canada
      • Toronto, Canada, M5G 2M9
        • Princess Margaret Hospital (Hong Kong)
      • Vancouver, Canada, V5Z4E6
        • BC Cancer Vancouver
  • China
      • Beijing, China, 100036
        • Beijing Cancer Hospital
      • Nanchang, China, 330009
        • The Third Hospital of Nanchang
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
  • France
      • Lyon, France, 69373
        • Centre Leon Berard
      • Paris, France, 75248
        • Institut Curie
      • Saint-Herblain, France, 44805
        • Institut de Cancérologie de l'Ouest
      • Strasbourg, France, 67033
        • ICANS_Institut de Cancerologie Strasbourg Europe
      • Villejuif, France, 94805
        • Gustave Roussy
  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
  • Japan
      • Chūōku, Japan, 104-0045
        • National Cancer Center Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Kōtō City, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Nagoya, Japan, 464-8681
        • Aichi Cancer Center Hospital
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 5505
        • Asan Medical Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08028
        • Hospital Universitario Quiron Dexeus
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Quironsalud Madrid
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova Valencia
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital (Sutton)
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic of Scottsdale
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay
      • Stanford, California, United States, 94305
        • Stanford University Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Center Emory University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0002
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University Medical School
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • Wilmot Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology PLLC
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75390-8884
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics (START)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)
  • Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
  • Have stopped all cancer treatment and have recovered from the major side effects
  • Have adequate organ function, as measured by blood tests
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

  • Patients must have

    • Measurable disease

      --- Patients with non-breast tumor types must have at least 1 measurable lesion

    • Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)

  • For patients with an estrogen receptor (ER)+ breast cancer diagnosis:

    • If female, must be postmenopausal
    • If male, must agree to use hormone suppression

  • Phase 1a:

    -- Dose escalation and backfill patients:

    • Advanced solid tumor
    • Patients may have had up to 5 prior regimens for advanced disease

  • Phase 1b:

    • Part A:

      • ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer
      • Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required

    • Part B:

      • ER+/HER2- advanced breast cancer
      • Patients may have had up to 2 prior regimens for advanced disease.

    • Part C:

      • ER+/HER2- advanced breast cancer

      • Patients may have had up to 5 prior regimens for advanced disease.

        ---- Prior CDK4/6 inhibitor therapy required.

      • Have a diagnosis of diabetes mellitus Type 2

    • Part D:

      • Advanced breast cancer
      • Patients may have had up to 5 prior regimens for advanced disease.

    • Part E:

      • Advanced solid tumor
      • Patients may have had up to 3 prior regimens for advanced disease advanced disease

    • Part F:

      • ER+/HER2- advanced breast cancer

      • Patients may have had up to 5 prior regimens for advanced disease

        • Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required

Exclusion Criteria:

  • Medical Conditions

    • Colorectal cancer
    • Endometrial cancers with specific concurrent oncogenic alterations

    • A history of known active or suspected

      • Diabetes mellitus Type 1 or
      • Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).
      • Serious concomitant systemic disorder
  • Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process
  • Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1A: LOXO-783 Monotherapy Dose Escalation
LOXO-783 administered orally
Drug: LOXO-783
Oral
Other Names:
  • LY3849524
Experimental: Phase 1B: Part B
LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally
Drug: LOXO-783
Oral
Other Names:
  • LY3849524
Drug: Fulvestrant
Intramuscular
Drug: Imlunestrant
Oral
Other Names:
  • LY3484356
Drug: Abemaciclib
Oral
Other Names:
  • LY2835219
Drug: Anastrozole, Exemestane, or Letrozole
Oral
Experimental: Phase 1B: Part C
LOXO-783 orally in combination with fulvestrant intramuscularly
Drug: LOXO-783
Oral
Other Names:
  • LY3849524
Drug: Fulvestrant
Intramuscular
Experimental: Phase 1B: Part D
LOXO-783 orally in combination with paclitaxel intravenously
Drug: Paclitaxel
Intravenous
Drug: LOXO-783
Oral
Other Names:
  • LY3849524
Experimental: Phase 1B: Part E
LOXO-783 orally
Drug: LOXO-783
Oral
Other Names:
  • LY3849524
Experimental: Phase 1B: Part A
LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally
Drug: LOXO-783
Oral
Other Names:
  • LY3849524
Drug: Fulvestrant
Intramuscular
Drug: Imlunestrant
Oral
Other Names:
  • LY3484356
Drug: Anastrozole, Exemestane, or Letrozole
Oral
Experimental: Phase 1B: Part F
Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly
Drug: LOXO-783
Oral
Other Names:
  • LY3849524
Drug: Fulvestrant
Intramuscular

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities
Time Frame: During the first 28-day cycle of LOXO-783 treatment
Number of patients with DLT-equivalent toxicities
During the first 28-day cycle of LOXO-783 treatment
Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)
Time Frame: During the first 28-day cycle of LOXO-783 treatment
Number of patients with DLTs
During the first 28-day cycle of LOXO-783 treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)
Time Frame: Up to 2 months
PK of LOXO-783: AUC
Up to 2 months
To assess the PK of LOXO-783: Maximum drug concentration (Cmax)
Time Frame: Up to 2 months
PK of LOXO-783: Cmax
Up to 2 months
To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)
Time Frame: Up to approximately 36 months or 3 years
BOR per investigator assessed RECIST 1.1
Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR)
Time Frame: Up to approximately 36 months or 3 years
DOR per investigator assessed RECIST 1.1
Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR)
Time Frame: Up to approximately 36 months or 3 years
DCR per investigator assessed RECIST 1.1
Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR)
Time Frame: Up to approximately 36 months or 3 years
CBR per investigator assessed RECIST 1.1
Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR)
Time Frame: Up to approximately 36 months or 3 years
TTR per investigator assessed RECIST 1.1
Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS)
Time Frame: Up to approximately 36 months or 3 years
PFS per investigator assessed RECIST 1.1
Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS)
Time Frame: Up to approximately 36 months or 3 years
OS per investigator assessed RECIST 1.1
Up to approximately 36 months or 3 years
To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR)
Time Frame: Up to approximately 36 months or 3 years
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Up to approximately 36 months or 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Loxo Oncology, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18394
  • LOXO-PIK-21001 (Other Identifier: Eli Lilly and Company)
  • J4C-OX-JZUA (Other Identifier: Eli Lilly and Company)
  • 2022-000175-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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