ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03) (ACE-Breast03)
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|ClinicalTrials.gov Identifier: NCT04829604|
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : January 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|HER2 Positive Metastatic Breast Cancer||Drug: ARX788||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One single arm, open label with intravenous infusion of ARX788|
|Masking:||None (Open Label)|
|Official Title:||A Global, Phase 2 Study of ARX788 in HER2-positive, Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM-1 or T-DXd, and/or Tucatinib-containing Regimens|
|Actual Study Start Date :||April 5, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||February 2025|
Experimental: HER2 positive metastatic breast cancer subjects whose disease is resistant or refractory
This global Phase 2 study is designed to assess anticancer activity and safety of ARX788 in HER2 positive metastatic breast cancer subjects whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens.
The investigational medicinal product (IMP), ARX788, will be administered every 4 weeks (Q4W) by intravenous (IV) infusion.
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
Other Name: antibody drug conjugate (ADC)
- Objective response rate (ORR) [ Time Frame: 2 Years ]
The confirmed objective response rate (ORR) of ARX788 based on RECIST 1.1 in HER2-positive breast cancer subjects whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens.
The ORR is defined as the number of subjects with a BOR of CR or PR divided by the number of response evaluable subjects.
- Duration of response (DOR) [ Time Frame: 2 years ]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.
- Best percent change in the sum of the longest diameters of measurable tumors [ Time Frame: 2 years ]The percent change at the best response data point compared to baseline.
- Best overall response (BOR) [ Time Frame: 2 year ]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)
- Disease control rate (DCR) [ Time Frame: 2 years ]DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates.
- Progression-free survival (PFS) [ Time Frame: 2 years ]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
- Overall survival (OS) [ Time Frame: 2 year ]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.
- The number of subjects experiencing adverse event TEAEs [ Time Frame: 2 years ]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.
- Maximum serum concentration (Cmax) for ARX788, total antibody, and pAF-AS269 [ Time Frame: Cycle 1 and cycle 3 ]Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, total antibody, and pAF-AS269
- Trough concentration (Ctrough) for ARX788, total antibody, and pAF-AS269 [ Time Frame: Cycle 1 and cycle 3 ]Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, total antibody, and pAF-AS269
- Area under the serum concentration-time curve (AUC) for ARX788, total antibody, and pAF-AS269 [ Time Frame: Cycle 1 and cycle 3 ]Pharmacokinetic parameter area under the serum concentration-time curve (AUC) for ARX788, total antibody, and pAF-AS269
- Incidence of anti-drug antibodies (ADAs) [ Time Frame: 2 years ]Incidence of anti-drug antibodies (ADAs) following intravenous administration of ARX788 in participants with HER2-positive metastatic breast cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829604
|Contact: Trial Inquiry||(858) firstname.lastname@example.org|
|Study Director:||Ambrx||Ambrx, Inc.|