Trial record 1 of 9 for:
ARX788
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
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| ClinicalTrials.gov Identifier: NCT04829604 |
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Recruitment Status :
Active, not recruiting
First Posted : April 2, 2021
Last Update Posted : October 26, 2022
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Sponsor:
Ambrx, Inc.
Information provided by (Responsible Party):
Ambrx, Inc.
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Brief Summary:
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HER2 Positive Metastatic Breast Cancer | Drug: ARX788 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 31 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | One single arm, open label with intravenous infusion of ARX788 |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd |
| Actual Study Start Date : | April 5, 2021 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: ARX788
The investigational medicinal product (IMP), ARX788, will be administered every 3 weeks (Q3W) by intravenous (IV) infusion.
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Drug: ARX788
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) |
Primary Outcome Measures :
- Objective response rate (ORR) [ Time Frame: 2 Years ]
The confirmed objective response rate (ORR) of ARX788 based on RECIST 1.1 in post T-DXd subjects ≤3L of HER2-targeted treatment in HER2 positive metastatic breast cancer.
The ORR is defined as the number of subjects with a BOR of CR or PR divided by the number of response evaluable subjects.
Secondary Outcome Measures :
- Objective response rate (ORR) [ Time Frame: 2 Years ]
The confirmed objective response rate (ORR) of ARX788 based on RECIST 1.1 in post T-DXd subjects with ≥ 4L of HER2-targeted treatment in HER2 positive metastatic breast cancer.
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 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.
- 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.
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years and older
- Life expectancy ≥ 6 months
- Eastern Cooperative Oncology Group Performance Status ≤ 1
- Her 2 Positive Metastatic breast cancer subjects previously treated with T-DXd
- 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 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
- Female subjects must be surgically sterile, or have a monogamous partner who is surgically sterile, or at postmenopausal, or who commits to use an acceptable form of birth control; male subjects must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control
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
- 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
- Clinically significant surgical intervention (excluding diagnostic biopsy) within 21 days of the first dose of ARX788
- Radiotherapy administered less than 21 days prior to the first dose of ARX788, or localized palliative radiotherapy administered less than 7 days prior to the first dose of ARX788, or radiotherapy-induced toxicity of Grade 2 or greater based on NCI-CTCAE v 5.0
- Pregnancy or breast feeding
- Known active HCV, HBV, and/or HIV infection
Information from the National Library of Medicine
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
Locations
Show 53 study locations
Sponsors and Collaborators
Ambrx, Inc.
Investigators
| Study Director: | Ambrx | Ambrx, Inc. |
| Responsible Party: | Ambrx, Inc. |
| ClinicalTrials.gov Identifier: | NCT04829604 |
| Other Study ID Numbers: |
ACE-Breast-03 |
| First Posted: | April 2, 2021 Key Record Dates |
| Last Update Posted: | October 26, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Ambrx, Inc.:
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HER2-postive Breast cancer Antibody drug |
Metastatic ARX788 HER2 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Immunoconjugates Immunologic Factors Physiological Effects of Drugs |