ARX788 in HER2-positive Metastatic Breast Cancer Patients

October 27, 2024 updated by: Min Yan, MD, Henan Cancer Hospital

Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive Advanced Breast Cancer

A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 75 years old (including upper and lower limits), male or female;
  • Unresectable locally advanced, recurrent or metastatic BC;
  • Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC;
  • Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
  • Has at least one measurable target lesion as per RECIST1.1 criteria;
  • Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment;
  • Adequate bone marrow, liver, kidney and coagulation function;
  • ECOG Performance Status Score of 0-1;
  • Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.

Exclusion Criteria:

  • Has known history to be allergic to any active ingredient or excipient of ARX788;
  • With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy;
  • Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment;
  • Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
  • Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
  • Has cardiac insufficiency;
  • Uncontrolled hypertension;
  • Has evidence of severe or uncontrollable systemic diseases;
  • Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial;
  • Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial;
  • Is unwilling or unable to stop wearing corneal contact lens during the trial;
  • Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
  • Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form;
  • Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ARX788
Drug: ARX788
2.2 mg/kg IV infusion on Day 1 of each 42-day treatment cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR)
Time Frame: up to 2 years
ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: up to 2 years
DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1.
up to 2 years
Duration of relief (DOR)
Time Frame: From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.
DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.
From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.
Progression-free survival (PFS)
Time Frame: From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.
PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first.
From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.
Overall survival (OS)
Time Frame: From the date of first dose of study drug to any-cause death, assessed up to 5 years
OS was defined as the time from the first dose of study drug to any-cause death.
From the date of first dose of study drug to any-cause death, assessed up to 5 years
The number of subjects experiencing adverse event TEAEs
Time Frame: up to 2 years
Number of participants with TEAEs as assessed by CTCAE v5.0
up to 2 years
Pharmacokinetic parameter: Maximum concentration (Cmax)
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Time to Cmax (tmax)
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Terminal half-life (t1/2)
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)]
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Area under the concentration-time curve from zero to the last quantifiable concentration [AUC(0-last)]
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Terminal rate constant (λz)
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Systemic clearance (CL)
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Volume of distribution (Vz)
Time Frame: At the end of Cycle 1 (each cycle is 42 days)
At the end of Cycle 1 (each cycle is 42 days)
Pharmacokinetic parameter: Volume of distribution at steady state (Vss)
Time Frame: At the end of Cycle 3 (each cycle is 42 days)
At the end of Cycle 3 (each cycle is 42 days)
Pharmacokinetic parameter: Trough concentration (Ctrough)
Time Frame: At the end of Cycle 3 (each cycle is 42 days)
At the end of Cycle 3 (each cycle is 42 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACE-Breast-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings