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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
11/06/2024
Titles & IDs
Public title
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
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Scientific title
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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Secondary ID [1]
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ACE-Breast-03
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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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.
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Timepoint [1]
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2 Years
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Secondary outcome [1]
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Duration of response (DOR)
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Assessment method [1]
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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.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Best overall response (BOR)
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Assessment method [2]
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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)
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Timepoint [2]
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2 year
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Secondary outcome [3]
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Disease control rate (DCR)
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Assessment method [3]
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DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Overall survival (OS)
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Assessment method [4]
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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.
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Timepoint [4]
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2 year
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Secondary outcome [5]
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Progression-free survival (PFS)
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Assessment method [5]
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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
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Timepoint [5]
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2 years
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Secondary outcome [6]
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The number of subjects experiencing adverse event TEAEs
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Assessment method [6]
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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.
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Maximum serum concentration (Cmax) for ARX788
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Assessment method [7]
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Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, ADC, total antibody, and pAF-AS269
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Timepoint [7]
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Cycle 1 and cycle 3
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Secondary outcome [8]
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Trough concentration (Ctrough) for ARX788
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Assessment method [8]
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Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, ADC, total antibody, and pAF-AS269
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Timepoint [8]
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Cycle 1 and cycle 3
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Secondary outcome [9]
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Area under the serum concentration-time curve (AUC) for ARX788
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Assessment method [9]
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Pharmacokinetic parameter area under the serum concentration-time curve (AUC) for ARX788, ADC, total antibody, and pAF-AS269
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Timepoint [9]
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Cycle 1 and cycle 3
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
71
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Research Site - South Brisbane
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Recruitment hospital [2]
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Research Site - Woolloongabba
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Recruitment hospital [3]
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Research Site - Clayton
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Recruitment hospital [4]
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Research Site - Frankston
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Recruitment hospital [5]
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Research Site - Geelong
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Recruitment hospital [6]
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Research Site - Melbourne
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Recruitment hospital [7]
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Research Site - Ringwood East
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Recruitment hospital [8]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment postcode(s) [6]
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- Melbourne
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Recruitment postcode(s) [7]
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3135 - Ringwood East
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Delaware
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United States of America
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Florida
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Georgia
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Illinois
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Kentucky
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Missouri
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Nebraska
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New Mexico
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New York
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Washington
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France
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Avignon Cedex 09
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France
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La Rochelle
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France
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Le Mans
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France
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Nice
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France
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Toulouse CEDEX 9
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Korea, Republic of
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Daegu
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Goyang-si
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Korea, Republic of
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Seongnam-si
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Seoul
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Korea, Republic of
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Suwon
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ambrx, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT04829604
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ambrx
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Address
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Ambrx, Inc.
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Email
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Contact person for public queries
Name
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Trial Inquiry
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Address
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Phone
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(858) 875-2400
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Fax
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Email
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[email protected]
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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
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