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ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

PHASE2RECRUITING

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd.

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Study details:

A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Age ≥ 18 years and older

Life expectancy ≥ 6 months

Unresectable or metastatic breast cancer subjects

Presence of at least one measurable lesion per RECIST v 1.1

Subjects must have an adequate tumor sample available for confirmation of HER2 status

Subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment in the metastatic setting. One of these prior treatments must have been treatment with T-DXd.

Subjects with stable brain metastases

Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade ≤1 as per the NCI-CTCAE v 5.0, except alopecia

Adequate organ functions

Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol

Exclusion criteria

History of allergic reactions to any component of ARX788.

Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease

Any active ocular infections or chronic corneal disorders

History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia within 12 months prior to enrollment

Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0). Patients with Grade 2 neuropathy can be enrolled at investigator's discretion

History of unstable central nervous system (CNS) metastases

Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases)

Any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic Covid-19 infections), or other conditions that could limit study compliance or interfere with assessments

Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of ARX788

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-10-26

Primary completion: 2025-06-01

Study completion finish: 2026-12-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT04829604

Intervention or treatment

DRUG: ARX788

Conditions

• HER2 Positive Metastatic Breast Cancer

Image related to HER2 Positive Metastatic Breast Cancer

Condition: HER2 Positive Metastatic Breast Cancer
DRUG: ARX788
South Brisbane, Queensland, Australia and more
Sponsor: Ambrx, Inc.

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Find a site

Closest Location:

Research Site

Research sites nearby

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Research Site
South Brisbane, Queensland, Australia
Research Site
Woolloongabba, Queensland, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Frankston, Victoria, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ARX788 The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.	DRUG: ARX788 The active pharmaceutical ingredient in ARX788 is an antibody drug conjugate (ADC) consisting of a humanized anti-HER2 monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two microtubule-disrupting payloads AS269

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Objective response rate (ORR)	To evaluate the confirmed objective response rate (ORR) as determined by Investigator assessment based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) following treatment with ARX788. The ORR is defined as the number of subjects with a BOR of CR or PR divided by the number of response evaluable subjects.	2 Years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Duration of response (DOR)	DOR is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first, will be computed for subjects with a BOR of CR or PR.	2 years
Best overall response (BOR)	BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started)	2 year
Disease control rate (DCR)	DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.	2 years
Overall survival (OS)	Overall survival (OS) is defined as the time from first dose of study therapy to the date of death (any cause). Subjects who are alive will be censored at the last known time that the subject was alive.	2 year
Progression-free survival (PFS)	PFS is defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first, will be computed for response evaluable subjects. Subjects will be censored at time of subsequent therapy	2 years
The number of subjects experiencing adverse event TEAEs	Patient safety and adverse events (AEs) will be evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0. All AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the treatment.	2 years
Maximum serum concentration (Cmax) for ARX788	Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, ADC, total antibody, and pAF-AS269	Cycle 1 and cycle 3
Trough concentration (Ctrough) for ARX788	Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, ADC, total antibody, and pAF-AS269	Cycle 1 and cycle 3
Area under the serum concentration-time curve (AUC) for ARX788	Pharmacokinetic parameter area under the serum concentration-time curve (AUC) for ARX788, ADC, total antibody, and pAF-AS269	Cycle 1 and cycle 3

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)