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Small Molecule Inhibitor

LOXO-783 for Breast Cancer (PIKASSO-01 Trial)

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part B: ER+/HER2- advanced breast cancer. Patients may have had up to 2 prior regimens for advanced disease
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 36 months or 3 years
Awards & highlights

PIKASSO-01 Trial Summary

This trial is to study the safety and effectiveness of LOXO-783 for treating breast cancer and other solid tumors.

Who is the study for?
This trial is for adults with advanced breast cancer or other solid tumors that have a specific gene change (PIK3CA mutation). Participants can have had several prior treatments but must be recovered from their side effects. They need to have measurable disease, adequate organ function, and an ECOG performance status of 0 or 1. Women should be postmenopausal; men agree to hormone suppression.Check my eligibility
What is being tested?
LOXO-783 is being tested for its safety and effectiveness in treating certain cancers. The study will explore how well it works on tumors with the PIK3CA gene mutation over a period of up to three years. Patients may also receive other standard cancer treatments like Fulvestrant or Abemaciclib as part of the study.See study design
What are the potential side effects?
Possible side effects include typical reactions seen with cancer therapies such as fatigue, nausea, diarrhea, blood count changes, and potential risks associated with hormonal changes due to treatment. Specific side effects related to LOXO-783 are not listed but would be monitored closely.

PIKASSO-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is ER+ and HER2- and I've had up to 2 treatments for advanced disease.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am a woman and postmenopausal or a man agreeing to hormone suppression for my ER+ breast cancer.
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I have ER+/HER2- advanced breast cancer, treated with up to 5 regimens and a CDK4/6 inhibitor. I also have Type 2 diabetes.
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My breast cancer is ER+ and HER2- and I've had up to 5 treatments for it, including CDK4/6 inhibitors.
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My advanced cancer has a specific PIK3CA mutation.
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I have advanced breast cancer and have had up to 5 treatments for it.
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I have an advanced solid tumor and have had up to 5 treatments for it.
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I have an advanced solid tumor and have had up to 5 treatments for it.
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I have breast cancer with at least one bone lesion.
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I have an advanced solid tumor and have had up to 3 treatments for it.
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I have a tumor outside the breast that can be measured.
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I have a stored tumor sample or have been approved without one.
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I have stopped all cancer treatments and recovered from major side effects.
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My blood tests show my organs are working well.
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My breast cancer is ER+ and HER2- and I've had CDK4/6 inhibitor therapy.

PIKASSO-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 36 months or 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 36 months or 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities
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)
Secondary outcome measures
To assess the PK of LOXO-783: Maximum drug concentration (Cmax)
To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)
To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)
+7 more

PIKASSO-01 Trial Design

7Treatment groups
Experimental Treatment
Group I: Phase 1B: Part FExperimental Treatment2 Interventions
Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly
Group II: Phase 1B: Part EExperimental Treatment1 Intervention
LOXO-783 orally
Group III: Phase 1B: Part DExperimental Treatment2 Interventions
LOXO-783 orally in combination with paclitaxel intravenously
Group IV: Phase 1B: Part CExperimental Treatment2 Interventions
LOXO-783 orally in combination with fulvestrant intramuscularly
Group V: Phase 1B: Part BExperimental Treatment5 Interventions
LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally
Group VI: Phase 1B: Part AExperimental Treatment4 Interventions
LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally
Group VII: Phase 1A: LOXO-783 Monotherapy Dose EscalationExperimental Treatment1 Intervention
LOXO-783 administered orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOXO-783
2023
Completed Phase 1
~30
Fulvestrant
2011
Completed Phase 3
~3700
Imlunestrant
2022
Completed Phase 1
~140
Abemaciclib
2019
Completed Phase 2
~1710
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,232 Total Patients Enrolled
63 Trials studying Breast Cancer
36,504 Patients Enrolled for Breast Cancer
Loxo Oncology, Inc.Industry Sponsor
65 Previous Clinical Trials
9,609 Total Patients Enrolled
1 Trials studying Breast Cancer
Vincent Chau, MD; PhDStudy DirectorLoxo Oncology, Inc.

Media Library

LOXO-783 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05307705 — Phase 1
Breast Cancer Research Study Groups: Phase 1B: Part F, Phase 1B: Part A, Phase 1B: Part B, Phase 1B: Part C, Phase 1B: Part D, Phase 1A: LOXO-783 Monotherapy Dose Escalation, Phase 1B: Part E
Breast Cancer Clinical Trial 2023: LOXO-783 Highlights & Side Effects. Trial Name: NCT05307705 — Phase 1
LOXO-783 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307705 — Phase 1
Breast Cancer Patient Testimony for trial: Trial Name: NCT05307705 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What key results is this trial seeking to achieve?

"During a 28-day period, this clinical trial aims to identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of LOXO-783. Secondary objectives include estimating its pharmacokinetics parameters such as area under concentration versus time curve and peak drug concentrations, plus assessing initial antitumor activity with duration of response metrics."

Answered by AI

How many healthcare facilities in Canada are conducting this medical experiment?

"This clinical trial is open for enrolment at specific medical centres, such as Texas Oncology-Baylor Charles A. Sammons Cancer Center in Dallas, START in San Antonio and the Memorial Sloan Kettering Cancer Center in New york and Massachusetts. Additionally, there are 8 other sites available to prospective participants."

Answered by AI

How many people are currently participating in this experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial is currently enrolling patients; it was first announced on May 11th 2022 and further updated November 11th of that same year. The research needs 300 participants from 8 different sites in order to be completed successfully."

Answered by AI

Can you explain the potential risk of administering LOXO-783 to individuals?

"Since this is a Phase 1 trial, which suggests an absence of substantial clinical data corroborating safety or efficacy, LOXO-783 was assigned a score of 1."

Answered by AI

Is it possible for new participants to join this medical experiment?

"Data hosted on clinicaltrials.gov verifies that this medical trial is actively seeking out participants. This research endeavour was first launched on May 11th 2022 and its details have been modified as of November 11th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
UCLA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

Has the trial entered phase 1b?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have MBC and progressed on Verzenio-Faslodex. New genetic testing reveals PI3KCA H1047R and ESR1 Y537S mutations, which may be effectively treated in this trial. My oncologist recommended that I apply for this trial.
PatientReceived no prior treatments
~149 spots leftby May 2025