Health TrialsbyHealthPanel

ARX788 in HER2-positive Metastatic Breast Cancer Patients

ConditionHER2-positive, Metastatic Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital

About this trial

A phase 2 study of ARX788 given every 6 weeks in HER2-positive, metastatic breast cancer patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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+);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • ARX788

    Drug

    2.2 mg/kg IV infusion on Day 1 of each 42-day treatment cycle.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: ARX788Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective remission rate (ORR)

ORR is defined as the percentage of participants in the analysis population who have CR or PR per RECIST 1.1.

Time frame
up to 2 years

Secondary outcomes

1

Disease control rate (DCR)

DCR is defined as the percentage of participants in the analysis population who have CR or PR or SD per RECIST 1.1.

Time frame
up to 2 years
2

Duration of relief (DOR)

DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.

Time frame
From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.
3

Progression-free survival (PFS)

PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first.

Time frame
From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.
4

Overall survival (OS)

OS was defined as the time from the first dose of study drug to any-cause death.

Time frame
From the date of first dose of study drug to any-cause death, assessed up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: