LOXO-783 for Breast Cancer

(PIKASSO-01 Trial)

Not currently recruiting at 90 trial locations

Overseen By Patient Advocacy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must be taking: CDK4/6 inhibitors

Must not be taking: Antidiabetic medications

Disqualifiers: Colorectal cancer, Endometrial cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called LOXO-783 for breast cancer and other solid tumors with a specific gene change (PIK3CA mutation). Participants will receive LOXO-783, often combined with other medications, to evaluate its effectiveness and potential side effects. The trial is open to individuals with advanced breast cancer or other solid tumors that have the PIK3CA mutation, provided they have recovered from previous treatments and have no major health issues. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop all cancer treatments and recover from major side effects before participating. The protocol does not specify about other medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that LOXO-783 is undergoing tests to determine its safety and effectiveness for treating breast cancer and other solid tumors with a specific gene change. This treatment is in the early testing stages, so detailed safety information remains limited. However, early studies aim to assess patient tolerance.

As LOXO-783 is being tested in humans for the first time, researchers closely monitor patient responses, whether the drug is used alone or with other medications. These observations help identify any side effects or risks. While specific data from these studies is not yet available, the main goal is to understand any safety concerns before wider use.

Early trials emphasize safety, so researchers will closely monitor the study. Prospective participants should discuss any concerns with their healthcare provider to make an informed decision. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LOXO-783 for breast cancer because it offers a novel approach by targeting specific cancer cell pathways. Unlike standard treatments like chemotherapy and hormone therapy, LOXO-783 is a targeted therapy that interferes with cancer cell growth at the molecular level, potentially leading to more precise and effective treatment. Additionally, LOXO-783 is administered orally, which can be more convenient and less invasive compared to traditional intravenous treatments. This new mechanism of targeting cancer cells could provide an alternative for patients who have not responded well to existing therapies.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that LOXO-783 targets a gene mutation called PIK3CA, often found in breast cancer. In this trial, participants may receive LOXO-783 alone or with other treatments. When used alone, only about 3% of patients benefit. However, combining it with treatments like fulvestrant or abemaciclib appears more promising. Early animal studies demonstrated that combining LOXO-783 with drugs like abemaciclib led to noticeable tumor shrinkage. While these early results are encouraging, further testing is needed to confirm the treatment's effectiveness in people. ^{1 2 5 6 7}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have an advanced solid tumor and have had up to 3 treatments for it.

My breast cancer is ER+ and HER2- and I've had up to 2 treatments for advanced disease.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I do not have any active, uncontrolled infections or significant diseases.

I have colorectal cancer.

You have a serious health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LOXO-783 as monotherapy or in combination with other anticancer therapies

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term if the disease does not progress

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• LOXO-783

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 1B: Part F Experimental Treatment 2 Interventions

Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly

Group II: Phase 1B: Part E Experimental Treatment 1 Intervention

LOXO-783 orally

Group III: Phase 1B: Part D Experimental Treatment 2 Interventions

LOXO-783 orally in combination with paclitaxel intravenously

Group IV: Phase 1B: Part C Experimental Treatment 2 Interventions

LOXO-783 orally in combination with fulvestrant intramuscularly

Group V: Phase 1B: Part B Experimental Treatment 5 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 A Experimental Treatment 4 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 Escalation Experimental Treatment 1 Intervention

LOXO-783 administered orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05307705

NCT05307705 | A Study of LOXO-783 in Patients With ... 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 ...

2. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/PS7-03/753565/Abstract-PS7-03-A-first-in-human-phase-1a-b-trial

Abstract PS7-03: A first-in-human phase 1a/b trial of LOXO ... Minimal activity was observed with LOXO-783 monotherapy (ORR/CBR in evaluable pts: 3%/17% [n=29]). In doublet therapy cohorts, ORR/CBR was 5%/ ...

3. assets.ctfassets.net assets.ctfassets.net/mpejy6umgthp/2LPXE0Ybu6oFUNa6S3CWHp/8e4c8372ef630975dcfe8d5a73b94b1c/SABCS2024_JHAVERI_DV-020704_PS7-03_.pdf

A first-in-human phase 1a/b trial of LOXO-783, a potent, highly ... ... cancer, bilateral breast cancer, esophageal squamous cell cancer ... efficacy data for additional patients in this cohort were not ...

4. withpower.com withpower.com/trial/phase-1-breast-cancer-3-2022-603ef

LOXO-783 for Breast Cancer (PIKASSO-01 Trial) This trial is testing LOXO-783, a new drug, to see if it is safe and effective for patients with breast cancer and other solid tumors that have a change in ...

5. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2022-0116.html

A Study of LOXO-783 Administered as Monotherapy and in ... 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 ...

6. trials.lilly.com trials.lilly.com/en-US/trial/338185

A Study of LOXO-783 in Patients With Breast Cancer/Other ... 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 ...

7. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT05307705

NCT05307705 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 ...