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

NCT05307705 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: 183942022-000175-40J4C-OX-JZUALOXO-PIK-21001
• Study Type: interventional
• Target: 193
• Locations: 12 countries
• Sites: 50

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

  Number of patients with DLTs

  During the first 28-day cycle of LOXO-783 treatment

• Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities

  Number of patients with DLT-equivalent toxicities

  During the first 28-day cycle of LOXO-783 treatment

Secondary Outcomes (10)

• To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)

  Up to 2 months

• To assess the PK of LOXO-783: Maximum drug concentration (Cmax)

  Up to 2 months

• To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR)

  Up to approximately 36 months or 3 years

• To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)

  Up to approximately 36 months or 3 years

• To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR)

  Up to approximately 36 months or 3 years

Study Arms (7)

Phase 1A: LOXO-783 Monotherapy Dose Escalation

EXPERIMENTAL

LOXO-783 administered orally

Drug: LOXO-783

Phase 1B: Part A

EXPERIMENTAL

LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally

Drug: LOXO-783; Drug: Fulvestrant; Drug: Imlunestrant; Drug: Anastrozole, Exemestane, or Letrozole

Phase 1B: Part B

EXPERIMENTAL

LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally

Drug: LOXO-783; Drug: Fulvestrant; Drug: Imlunestrant; Drug: Abemaciclib; Drug: Anastrozole, Exemestane, or Letrozole

Phase 1B: Part C

EXPERIMENTAL

LOXO-783 orally in combination with fulvestrant intramuscularly

Drug: LOXO-783; Drug: Fulvestrant

Phase 1B: Part D

EXPERIMENTAL

LOXO-783 orally in combination with paclitaxel intravenously

Drug: LOXO-783; Drug: Paclitaxel

Phase 1B: Part E

EXPERIMENTAL

LOXO-783 orally

Drug: LOXO-783

Phase 1B: Part F

EXPERIMENTAL

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

Drug: LOXO-783; Drug: Fulvestrant

Interventions

LOXO-783 DRUG

Oral

Also known as: LY3849524

Phase 1A: LOXO-783 Monotherapy Dose Escalation; Phase 1B: Part A; Phase 1B: Part B; Phase 1B: Part C; Phase 1B: Part D; Phase 1B: Part E; Phase 1B: Part F

Fulvestrant DRUG

Intramuscular

Phase 1B: Part A; Phase 1B: Part B; Phase 1B: Part C; Phase 1B: Part F

Imlunestrant DRUG

Oral

Also known as: LY3484356

Phase 1B: Part A; Phase 1B: Part B

Abemaciclib DRUG

Oral

Also known as: LY2835219

Phase 1B: Part B

Anastrozole, Exemestane, or Letrozole DRUG

Oral

Phase 1B: Part A; Phase 1B: Part B

Paclitaxel DRUG

Intravenous

Phase 1B: Part D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (50)

Mayo Clinic of Scottsdale

Scottsdale, Arizona, 85259, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

Location

Stanford University Hospital

Stanford, California, 94305, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Winship Cancer Center Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905-0002, United States

Location

Washington University Medical School

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-8884, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Cancer Research SA

Adelaide, 5000, Australia

Location

Peter Maccallum Cancer Institute Erb

East Melbourne, 3002, Australia

Location

St Vincent's Hospital

Sydney, 2010, Australia

Location

Institut Jules Bordet

Anderlecht, 1070, Belgium

Location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Princess Margaret Hospital (Hong Kong)

Toronto, M5G 2M9, Canada

Location

BC Cancer Vancouver

Vancouver, V5Z4E6, Canada

Location

Beijing Cancer hospital

Beijing, 100036, China

Location

The Third Hospital of Nanchang

Nanchang, 330009, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Curie

Paris, 75248, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

ICANS_Institut de Cancerologie Strasbourg Europe

Strasbourg, 67033, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

National Cancer Center Hospital

Chūōku, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Kōtō City, 135-8550, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Aichi Cancer Center Hospital

Nagoya, 464-8681, Japan

Location

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Quironsalud Madrid

Pozuelo de Alarcón, 28223, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Arnau de Vilanova Valencia

Valencia, 46015, Spain

Location

Royal Marsden NHS Trust

London, SW3 6JJ, United Kingdom

Location

Royal Marsden Hospital (Sutton)

Sutton, SM2 5PT, United Kingdom

Location

Related Links

• A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Imlunestrant; abemaciclib; Anastrozole; exemestane; Letrozole; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 1, 2022
• Study Start: May 11, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); BE (2); SG (1); AU (3); FR (5); GB (2); US (17); DE (1); KR (2); CN (3); JP (4); CA (2)