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Monoclonal Antibodies

ARX788 for HER2-Positive Breast Cancer (ACE-Breast03 Trial)

Phase 2
Recruiting
Research Sponsored by Ambrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years and older
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

ACE-Breast03 Trial Summary

This trial is testing a new drug for people with HER2-positive breast cancer that has spread. The drug is being tested to see if it is better than the current standard of care.

Who is the study for?
This trial is for adults with HER2-positive metastatic breast cancer who've had no more than 5 systemic treatments in the metastatic setting, including T-DXd. They must have stable brain metastases, resolved any acute toxicities to Grade ≤1 (except hair loss), and have a measurable lesion. People can't join if they've recently used other cancer treatments, have certain lung or heart conditions, severe uncontrolled diseases, active infections like COVID-19, or unstable brain metastases.Check my eligibility
What is being tested?
The study tests ARX788 on patients with advanced breast cancer who previously received T-DXd treatment. It's a global Phase 2 trial focusing on those whose disease has spread and are looking for new treatment options after traditional therapies.See study design
What are the potential side effects?
While specific side effects of ARX788 aren't listed here, common ones may include allergic reactions to its components; it also excludes individuals with histories of significant lung disease suggesting potential respiratory risks.

ACE-Breast03 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I've had 5 or fewer treatments for my cancer, including T-DXd.
Select...
I can carry out all my self-care but cannot do heavy physical work.
Select...
My brain cancer has not grown or spread.
Select...
My breast cancer cannot be removed by surgery or has spread.

ACE-Breast03 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Area under the serum concentration-time curve (AUC) for ARX788
Best overall response (BOR)
Disease control rate (DCR)
+6 more
Other outcome measures
Evaluate Biomarker

Side effects data

From 2021 Phase 1 & 2 trial • 331 Patients • NCT02257567
67%
FATIGUE
50%
ALOPECIA
50%
DECREASED APPETITE
50%
CONSTIPATION
50%
NAUSEA
50%
INSOMNIA
33%
HYPOPHOSPHATAEMIA
33%
RASH
33%
NEUTROPENIA
33%
VOMITING
33%
NIGHT SWEATS
33%
DIARRHOEA
33%
WEIGHT DECREASED
33%
HYPERGLYCAEMIA
33%
DYSPNOEA
17%
PLATELET COUNT DECREASED
17%
PRURITUS
17%
ARTHROPOD BITE
17%
SKIN DISCOLOURATION
17%
THROMBOCYTOPENIA
17%
HYPERTENSION
17%
GLAUCOMA
17%
STOMATITIS
17%
CHILLS
17%
FOLLICULITIS
17%
BONE PAIN
17%
HERPES ZOSTER
17%
INFUSION RELATED REACTION
17%
LYMPHOCYTE COUNT DECREASED
17%
HYPOMAGNESAEMIA
17%
HYPOKALAEMIA
17%
NEUROPATHY PERIPHERAL
17%
PERIPHERAL SENSORY NEUROPATHY
17%
EYE PRURITUS
17%
VISION BLURRED
17%
FLATULENCE
17%
SINUSITIS
17%
ENDOMETRIAL ADENOCARCINOMA
17%
ENDOMETRIAL CANCER
17%
ANAEMIA
17%
ABDOMINAL PAIN
17%
MUSCULAR WEAKNESS
17%
COUGH
17%
DYSPNOEA EXERTIONAL
17%
DRY SKIN
17%
MOUTH ULCERATION
17%
PALLOR
17%
EYE DISCHARGE
17%
VITAMIN D DEFICIENCY
17%
SINUS CONGESTION
17%
ATRIAL FIBRILLATION
17%
PYREXIA
17%
DIZZINESS
17%
PERIPHERAL SWELLING
17%
HODGKIN'S DISEASE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
Arm A (Phase II Randomization): Pola+BR in FL
Arm B (Phase II Randomization): BR in FL
Arm C (Phase II Randomization): Pola+BR in DLBCL
Arm D (Phase II Randomization): BR in DLBCL
Arm E (Phase II Expansion): Pola+BG in FL
Arm F (Phase II Expansion): Pola+BG in DLBCL
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

ACE-Breast03 Trial Design

1Treatment groups
Experimental Treatment
Group I: ARX788Experimental Treatment1 Intervention
The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARX788
2018
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Ambrx, Inc.Lead Sponsor
7 Previous Clinical Trials
659 Total Patients Enrolled
AmbrxStudy DirectorAmbrx, Inc.
2 Previous Clinical Trials
328 Total Patients Enrolled

Media Library

ARX788 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04829604 — Phase 2
Breast Cancer Research Study Groups: ARX788
Breast Cancer Clinical Trial 2023: ARX788 Highlights & Side Effects. Trial Name: NCT04829604 — Phase 2
ARX788 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04829604 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you detail the potential dangers of ARX788 to humans?

"There is preliminary clinical data affirming ARX788's safety, thus it was rated a 2."

Answered by AI

Is enrollment in this clinical trial still open for participation?

"According to the clinicaltrials.gov website, this research study is no longer accepting participants despite being initially posted on April 5th 2021 and last updated October 25 2022. However, there are currently 2282 other medical studies actively recruiting patients."

Answered by AI

How many locations in the state are conducting this investigation?

"This clinical trial has recruited 66 patients, with major enrolment sites including Oncology Institute of Hope and Innovation in Corona, Research Site in Silver Spring, and Memorial Regional Hospital in Newark. Other medical centres are also participating."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
Iowa
What site did they apply to?
Northwestern University- Feinberg School of Medicine
Research Site
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I bilieve its personalice.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
2021. "ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04829604.
All > Breast Cancer Albuquerque
~21 spots leftby Jun 2025
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