Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04829604
Registration number
NCT04829604
Ethics application status
Date submitted
18/03/2021
Date registered
2/04/2021
Date last updated
11/06/2024
Titles & IDs
Public title
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
Query!
Scientific title
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
Query!
Secondary ID [1]
0
0
ACE-Breast-03
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Metastatic Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - ARX788
Experimental: ARX788 - The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.
Treatment: Drugs: ARX788
The active pharmaceutical ingredient in ARX788 is an antibody drug conjugate (ADC) consisting of a humanized anti-HER2 monoclonal antibody (mAb) (IgG1?) covalently conjugated to two microtubule-disrupting payloads AS269
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Objective response rate (ORR)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
2 Years
Query!
Secondary outcome [1]
0
0
Duration of response (DOR)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [2]
0
0
Best overall response (BOR)
Query!
Assessment method [2]
0
0
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)
Query!
Timepoint [2]
0
0
2 year
Query!
Secondary outcome [3]
0
0
Disease control rate (DCR)
Query!
Assessment method [3]
0
0
DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.
Query!
Timepoint [3]
0
0
2 years
Query!
Secondary outcome [4]
0
0
Overall survival (OS)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
2 year
Query!
Secondary outcome [5]
0
0
Progression-free survival (PFS)
Query!
Assessment method [5]
0
0
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
Query!
Timepoint [5]
0
0
2 years
Query!
Secondary outcome [6]
0
0
The number of subjects experiencing adverse event TEAEs
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
2 years
Query!
Secondary outcome [7]
0
0
Maximum serum concentration (Cmax) for ARX788
Query!
Assessment method [7]
0
0
Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, ADC, total antibody, and pAF-AS269
Query!
Timepoint [7]
0
0
Cycle 1 and cycle 3
Query!
Secondary outcome [8]
0
0
Trough concentration (Ctrough) for ARX788
Query!
Assessment method [8]
0
0
Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, ADC, total antibody, and pAF-AS269
Query!
Timepoint [8]
0
0
Cycle 1 and cycle 3
Query!
Secondary outcome [9]
0
0
Area under the serum concentration-time curve (AUC) for ARX788
Query!
Assessment method [9]
0
0
Pharmacokinetic parameter area under the serum concentration-time curve (AUC) for ARX788, ADC, total antibody, and pAF-AS269
Query!
Timepoint [9]
0
0
Cycle 1 and cycle 3
Query!
Eligibility
Key inclusion criteria
Key
* 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
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Any subject who meets any of the following criteria is excluded from the study:
* 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/10/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2026
Query!
Actual
Query!
Sample size
Target
71
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Research Site - South Brisbane
Query!
Recruitment hospital [2]
0
0
Research Site - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Research Site - Clayton
Query!
Recruitment hospital [4]
0
0
Research Site - Frankston
Query!
Recruitment hospital [5]
0
0
Research Site - Geelong
Query!
Recruitment hospital [6]
0
0
Research Site - Melbourne
Query!
Recruitment hospital [7]
0
0
Research Site - Ringwood East
Query!
Recruitment hospital [8]
0
0
Research Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [5]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [6]
0
0
- Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3135 - Ringwood East
Query!
Recruitment postcode(s) [8]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Delaware
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Louisiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Missouri
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nebraska
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nevada
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Mexico
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Oregon
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Avignon Cedex 09
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
La Rochelle
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Le Mans
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Nice
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Toulouse CEDEX 9
Query!
Country [26]
0
0
Korea, Republic of
Query!
State/province [26]
0
0
Daegu
Query!
Country [27]
0
0
Korea, Republic of
Query!
State/province [27]
0
0
Goyang-si
Query!
Country [28]
0
0
Korea, Republic of
Query!
State/province [28]
0
0
Seongnam-si
Query!
Country [29]
0
0
Korea, Republic of
Query!
State/province [29]
0
0
Seoul
Query!
Country [30]
0
0
Korea, Republic of
Query!
State/province [30]
0
0
Suwon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Ambrx, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
Query!
Trial website
https://clinicaltrials.gov/study/NCT04829604
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Ambrx
Query!
Address
0
0
Ambrx, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Trial Inquiry
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
(858) 875-2400
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT04829604
Download to PDF