HER2-positive, Metastatic Breast Cancer
Conditions
Keywords
ARX788, HER2-positive breast cancer, Q6W
Brief summary
A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.
Detailed description
A single arm, phase 2 study of ARX788 in HER2-positive, metastatic breast cancer patients. The ARX788 will be administered every 6 weeks (Q6W) intravenous (IV) infusion.
Interventions
DRUGARX788
2.2 mg/kg IV infusion on Day 1 of each 42-day treatment cycle.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 75 years old (including upper and lower limits), male or female; * Unresectable locally advanced, recurrent or metastatic BC; * Has previously received ≤ two lines of chemotherapy (excluding hormone therapy) for recurrent or metastatic BC; * Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+); * Has at least one measurable target lesion as per RECIST1.1 criteria; * Has recovered from any AE (≤ Grade 1) related to prior surgery and prior cancer treatment; * Adequate bone marrow, liver, kidney and coagulation function; * ECOG Performance Status Score of 0-1; * Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.
Exclusion criteria
* Has known history to be allergic to any active ingredient or excipient of ARX788; * With meningeal metastases or disseminated brain metastases or active brain metastases, who need radiation, surgery or drug therapy; * Has pericardial effusion, pleural effusion or ascites effusion with clinical symptoms, signs or require symptomatic treatment; * Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease; * Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection; * Has cardiac insufficiency; * Uncontrolled hypertension; * Has evidence of severe or uncontrollable systemic diseases; * Received live vaccines within 4 weeks before the first use of the investigational product or plans to receive live vaccines during the trial; * Breastfeeding female, or who has childbearing potential with a positive baseline pregnancy test or who is unwilling to use effective contraception during the trial; * Is unwilling or unable to stop wearing corneal contact lens during the trial; * Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product; * Has any mental or cognitive disorder that may restrict his/her understanding and execution of the informed consent form; * Other conditions that the Investigator considers inappropriate for participation in this trial, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate (ORR) | up to 2 years | ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | up to 2 years | DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1. |
| Duration of relief (DOR) | From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years. | DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first. |
| Progression-free survival (PFS) | From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years. | PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first. |
| Overall survival (OS) | From the date of first dose of study drug to any-cause death, assessed up to 5 years | OS was defined as the time from the first dose of study drug to any-cause death. |
| The number of subjects experiencing adverse event TEAEs | up to 2 years | Number of participants with TEAEs as assessed by CTCAE v5.0 |
| Pharmacokinetic parameter: Maximum concentration (Cmax) | At the end of Cycle 1 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Time to Cmax (tmax) | At the end of Cycle 1 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)] | At the end of Cycle 1 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Area under the concentration-time curve from zero to the last quantifiable concentration [AUC(0-last)] | At the end of Cycle 1 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Terminal rate constant (λz) | At the end of Cycle 1 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Systemic clearance (CL) | At the end of Cycle 1 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Volume of distribution (Vz) | At the end of Cycle 1 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Volume of distribution at steady state (Vss) | At the end of Cycle 3 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Trough concentration (Ctrough) | At the end of Cycle 3 (each cycle is 42 days) | — |
| Pharmacokinetic parameter: Terminal half-life (t1/2) | At the end of Cycle 1 (each cycle is 42 days) | — |
Contacts
Primary ContactMin Yan
Outcome results
None listed