A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System

NCT ID: NCT05275010

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2023-10-03

Brief Summary

This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using the proprietary on-body delivery system or a handheld syringe with hypodermic needle.

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1: PH FDC SC Using a Handheld Syringe

A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using a handheld syringe with hypodermic needle.

Group Type: ACTIVE_COMPARATOR

Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC)

Intervention Type: DRUG

A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the anterior thigh, using either a handheld syringe with hypodermic needle (Arm 1) or the on-body delivery system (Arm 2).

Handheld Syringe with Hypodermic Needle

Intervention Type: DEVICE

A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using a handheld manual syringe.

Arm 2: PH FDC SC Using the OBDS

A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the participant's anterior thigh on Day 1, using the on-body delivery system (OBDS).

Group Type: EXPERIMENTAL

Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC)

Intervention Type: DRUG

A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the anterior thigh, using either a handheld syringe with hypodermic needle (Arm 1) or the on-body delivery system (Arm 2).

On-Body Delivery System

Intervention Type: DEVICE

A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using the on-body delivery system (OBDS).

Interventions

Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (PH FDC SC)

A single dose of PH FDC SC (600 mg pertuzumab/600 mg trastuzumab) will be administered by a healthcare professional subcutaneously (SC) into the anterior thigh, using either a handheld syringe with hypodermic needle (Arm 1) or the on-body delivery system (Arm 2).

Intervention Type: DRUG

Handheld Syringe with Hypodermic Needle

A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using a handheld manual syringe.

Intervention Type: DEVICE

On-Body Delivery System

A single 10-mL dose of PH FDC SC will be administered as a subcutaneous (SC) injection using the on-body delivery system (OBDS).

Intervention Type: DEVICE

Other Intervention Names

Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf; PHESGO®; RO7198574; RG6264

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects age 18-45 years at time of signing Informed Consent Form
• Ability to comply with the study protocol
• Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, during the treatment period and for 7 months after the dose of PH FDC SC
• A body mass index (BMI) between 18 and 32 kilograms per metre squared (kg/m2), inclusive
• Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection on the thighs
• Baseline LVEF≥55% measured by echocardiogram (ECHO)
• No history of hypersensitivity or confirmed, clinically significant and clinically relevant allergic reactions, either spontaneously or following any drug administration
• No history of any clinically significant and clinically relevant cardiac condition
• No history of previous anticancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs
• No apparent family history of clinically significant and clinically relevant hypersensitivity, allergy, and severe cardiac diseases
• No contraindications from detailed medical and surgical history and physical examinations
• No previous enrollment in this study protocol and no concurrent enrollment in any other study protocol

Exclusion Criteria

• Positive urine test for drugs of abuse as per local standard (for alcohol abuse, positive breath test is also acceptable)
• Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) 1 or 2, showing: History of exposure to HBV, HCV, or HIV; or Active viral hepatitis infection (HBV or HCV) or HIV infection
• Systolic blood pressure ≥140 millimetres of mercury (mmHg) or <90 mmHg, or diastolic blood pressure >90 mmHg or <50 mmHg
• Use of prohibited medications including non-prescription medications, nutraceuticals, nutritional supplements or any herbal remedies taken within 10 days or 5 times the elimination half-life (whichever is longer) prior to randomization into the study
• Concomitant subcutaneous, intravenous, or any parenteral drugs within 90 days prior to screening
• Participation in an investigational drug or device study within 90 days or five times the elimination half-life (whichever is longer) prior to screening
• Donation of blood over 500 millilitres (mL) within 3 months prior to enrollment
• Known severe hypersensitivity to plaster, medical adhesive tapes, or bandages
• Known allergy to murine proteins, hyaluronidase, bee, or vespid venom, or any other ingredient in the formulation of rHuPH20 (Hylenex® recombinant [hyaluronidase human injection]) or any other ingredients and excipients in the formulation of PH FDC SC
• Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, CBC, chemistry panel, and urinalysis)
• Clinically relevant electrocardiogram abnormalities at screening or Day -1
• History of any cardiac condition
• Lower extremity edema or pathology (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, previous lymph node dissection etc.) that could interfere with any protocol-specified outcome assessment
• Any history of clinically significant and clinically relevant allergies, oncologic, psychiatric, gastrointestinal, renal, hepatic, cardiovascular or pulmonary disease
• Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in this study
• Any clinically relevant history of systemic disease (e.g., malignancy, diabetes mellitus, gastrointestinal, renal, hepatic, cardiovascular, rheumatological, or pulmonary disease)
• History of breast cancer or treatment for breast cancer
• Current chronic daily treatment (continuous for >3 months) with corticosteroids (dose ≥10 mg/day methylprednisolone), excluding inhaled corticosteroids
• Receipt of intravenous antibiotics for infection within 7 days prior to enrollment into the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Q-Pharm Pty Ltd; Nucleus Network Brisbane Clinic

Herston, Queensland, Australia

CMAX Pty Ltd

Adelaide, South Australia, Australia

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

New Zealand Clinical Research - Auckland

Auckland, , New Zealand

New Zealand Clinical Research - Christchurch

Christchurch, , New Zealand

Countries

Australia; New Zealand

References

Wynne C, Wang B, Deng R, Li J, Eiger D, Bene Tchaleu F, Heeson S, Restuccia E. Pharmacokinetic bioequivalence of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using a handheld syringe or an on-body delivery system. J Cancer Res Clin Oncol. 2025 Jun 14;151(6):188. doi: 10.1007/s00432-025-06228-4.

Reference Type: DERIVED

PMID: 40514611 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

WP42873

Identifier Type: -

Identifier Source: org_study_id