Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04829604
  4. Details
NCT04829604 Clinical Trial

ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)

HER2 Positive Metastatic Breast Cancer Clinical Trial

Official title:
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04829604
Other study ID # ACE-Breast-03
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 26, 2021
Est. completion date December 2026

Study information
Verified date June 2024
Source Ambrx, Inc.
Contact Trial Inquiry
Phone (858) 875-2400
Email breast03trialinquiry@ambrx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd

Description:

A Global, Single Arm, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
See more »

Sponsors (1)
Lead Sponsor Collaborator
Ambrx, Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Evaluate Biomarker To evaluate exploratory blood- and tissue-based biomarkers related to study drug response 2 years
Primary Objective response rate (ORR) 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.		 2 Years
Secondary Duration of response (DOR) 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. 2 years
Secondary Best overall response (BOR) 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) 2 year
Secondary Disease control rate (DCR) DCR is defined as the proportion of complete response (CR), partial response (PR), and stable disease (SD) rates. 2 years
Secondary Overall survival (OS) 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. 2 year
Secondary Progression-free survival (PFS) 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 2 years
Secondary The number of subjects experiencing adverse event TEAEs 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. 2 years
Secondary Maximum serum concentration (Cmax) for ARX788 Pharmacokinetic parameter maximum serum concentration (Cmax) for ARX788, ADC, total antibody, and pAF-AS269 Cycle 1 and cycle 3
Secondary Trough concentration (Ctrough) for ARX788 Pharmacokinetic parameter trough concentration (Ctrough) for ARX788, ADC, total antibody, and pAF-AS269 Cycle 1 and cycle 3
Secondary Area under the serum concentration-time curve (AUC) for ARX788 Pharmacokinetic parameter area under the serum concentration-time curve (AUC) for ARX788, ADC, total antibody, and pAF-AS269 Cycle 1 and cycle 3
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03691051 - A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer Phase 2
Active, not recruiting NCT03080805 - Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE) Phase 3
Active, not recruiting NCT02422199 - A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab Phase 1/Phase 2
Terminated NCT01495884 - The Myocet/Lapatinib Study. ICORG 10-03, V5 Phase 1/Phase 2
Active, not recruiting NCT02973737 - A Study of Pyrotinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Phase 3
Completed NCT04398108 - A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC Phase 1
Active, not recruiting NCT04681287 - Exploratory Study of Advanced Breast Cancer in HER2 Positive Patients With Failure of Multi-line Therapy Treated by Combination of Inetetamab (Cipterbin) + PD-1 Inhibitor Combined With Utidelone. Phase 2