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

Breast Cancer Clinical Trial

— PIKASSO-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307705
• Other study ID #: LOXO-PIK-21001
• Secondary ID: J4C-OX-JZUA2022-
• Status: Recruiting
• Phase: Phase 1
• Start date: May 11, 2022
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: Patient Advocacy
• Phone: 855-569-6305
• Email: clinicaltrials[@]loxooncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• LOXO-783
Oral
• Fulvestrant
Intramuscular
• Imlunestrant
Oral
• Abemaciclib
Oral
• Anastrozole, Exemestane, or Letrozole
Oral
• Paclitaxel
Intravenous

Locations

Country	Name	City	State
Australia	Cancer Research SA	Adelaide SA
Australia	Peter MacCallum Cancer Center	Melbourne
Australia	St Vincent's Hospital Sydney	Sydney	New South Wales
Belgium	Institut Jules Bordet Brussels	Brussels
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Canada	Princess Margaret Hospital	Toronto
Canada	BC Cancer Center	Vancouver
China	Beijing Cancer Hospital	Beijing
China	Hunan Cancer Hospital	Changsha
China	Third Hospital of Nanchang	Nanchang
China	Fudan University Cancer Center	Shanghai
France	Institut de Cancérologie de l'Ouest	Angers
France	Centre François Baclesse	Caen
France	Centre Leon Berard	Lyon
France	Institut Curie	Paris
France	ICANS Strasbourg	Strasbourg
France	Gustave Roussy	Villejuif
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt	Hessen
Germany	Universitaetsklinikum Tuebingen	Tuebingen	Württemberg
Italy	Istituto Europeo di Oncologia IRCCS	Milano
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Koto City	Tokyo
Japan	Kyoto University Hospital	Kyoto
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Singapore	National Cancer Center	Singapore
Spain	Hospital Clinic y Provincial de Barcelona	Barcelona
Spain	Hospital Universitari Quiron Dexeus	Barcelona
Spain	Vall d'Hebron	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Quironsalud Madrid	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Arnau de Vilanova Valencia	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia
United Kingdom	Royal Marsden NHS Trust	London	Greater London
United Kingdom	Royal Marsden Hospital (Sutton) Loc. 6	Sutton	Surrey
United States	Emory University	Atlanta	Georgia
United States	DFCI	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic-Jacksonville	Jacksonville	Florida
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Stanford University	Palo Alto	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Wilmot Cancer Institute	Rochester	New York
United States	Washington University Medical School	Saint Louis	Missouri
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas
United States	UCSF	San Francisco	California
United States	UCLA	Santa Monica	California
United States	Mayo Clinic of Scottsdale	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Singapore,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)	PK of LOXO-783: AUC	Up to 2 months
Secondary	To assess the PK of LOXO-783: Maximum drug concentration (Cmax)	PK of LOXO-783: Cmax	Up to 2 months
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to approximately 36 months or 3 years
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)	BOR per investigator assessed RECIST 1.1	Up to approximately 36 months or 3 years
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR)	DOR per investigator assessed RECIST 1.1	Up to approximately 36 months or 3 years
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR)	DCR per investigator assessed RECIST 1.1	Up to approximately 36 months or 3 years
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR)	CBR per investigator assessed RECIST 1.1	Up to approximately 36 months or 3 years
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR)	TTR per investigator assessed RECIST 1.1	Up to approximately 36 months or 3 years
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS)	PFS per investigator assessed RECIST 1.1	Up to approximately 36 months or 3 years
Secondary	To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS)	OS per investigator assessed RECIST 1.1	Up to approximately 36 months or 3 years

External Links

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