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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
25/03/2025

Titles & IDs
Public title
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
Scientific title
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
Secondary ID [1] 0 0
ACE-Breast-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
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.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Duration of response (DOR)
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.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Best overall response (BOR)
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)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Disease control rate (DCR)
Assessment method [3] 0 0
DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Overall survival (OS)
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.
Timepoint [4] 0 0
2.5 years
Secondary outcome [5] 0 0
Progression-free survival (PFS)
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
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
The number of subjects experiencing adverse event TEAEs
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.
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Maximum serum concentration (Cmax) for ARX788
Assessment method [7] 0 0
Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, ADC, ADA, total antibody, and pAF-AS269
Timepoint [7] 0 0
Cycle 1 and cycle 3
Secondary outcome [8] 0 0
Trough concentration (Ctrough) for ARX788
Assessment method [8] 0 0
Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, ADC, total antibody, and pAF-AS269
Timepoint [8] 0 0
Cycle 1 and cycle 3
Secondary outcome [9] 0 0
Area under the serum concentration-time curve (AUC) for ARX788
Assessment method [9] 0 0
Pharmacokinetic parameter area under the serum concentration-time curve (AUC) for ARX788, ADC, total antibody, and pAF-AS269
Timepoint [9] 0 0
Cycle 1 and cycle 3
Secondary outcome [10] 0 0
Time to response (TTR)
Assessment method [10] 0 0
Time it takes for patient to respond to study treatment
Timepoint [10] 0 0
Start of treatment to first objective confirmed BOR of CR or PR, assessed for approximately 2 years

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 HER2 positive breast cancer per ASCO-CAP guidelines, documented in a CLIA lab pathology report
* Subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment HER-2 targeting therapy or chemotherapy 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, vitiligo, Grade 2 peripheral neuropathy, or endocrine toxicities that are stable on hormone replacement.
* Adequate organ functions
* Willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 requirement for supplemental oxygen.
* Any active ocular infections or chronic corneal disorders
* History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment
* Grade 3 to 4 peripheral neuropathy (NCI CTCAE v 5.0).
* History of unstable central nervous system (CNS) metastases
* Radiotherapy outside of the brain administered < 7 days prior to first dose of ARX788
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
71
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - South Brisbane
Recruitment hospital [2] 0 0
Research Site - Woolloongabba
Recruitment hospital [3] 0 0
Research Site - Clayton
Recruitment hospital [4] 0 0
Research Site - Frankston
Recruitment hospital [5] 0 0
Research Site - Geelong
Recruitment hospital [6] 0 0
Research Site - Melbourne
Recruitment hospital [7] 0 0
Research Site - Ringwood East
Recruitment hospital [8] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
3135 - Ringwood East
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
France
State/province [22] 0 0
Avignon Cedex 09
Country [23] 0 0
France
State/province [23] 0 0
La Rochelle
Country [24] 0 0
France
State/province [24] 0 0
Le Mans
Country [25] 0 0
France
State/province [25] 0 0
Nice
Country [26] 0 0
France
State/province [26] 0 0
Toulouse CEDEX 9
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Daegu
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Goyang-si
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seongnam-si
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Suwon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ambrx, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Ambrx
Address 0 0
Ambrx, Inc.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Inquiry
Address 0 0
Country 0 0
Phone 0 0
(858) 875-2400
Email 0 0
breast03trialinquiry@ambrx.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04829604