Clinical trial NCT06663748: ARX788 in HER2-positive Metastatic Breast Cancer Patients
Official title: Evaluate the Efficacy and Safety of ARX788 Given Every 6 Weeks in Patients with HER2-positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: HER2-positive, Metastatic Breast Cancer
Keywords: ARX788
HER2-positive breast cancer
Q6W
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective remission rate (ORR)
timeFrame: up to 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: up to 2 years
measure: Duration of relief (DOR)
timeFrame: From response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first, assessed up to 2 years.
measure: Progression-free survival (PFS)
timeFrame: From first dose to first documented disease progression (PD) or death from any cause, whichever occurred first, assessed up to 2 years.
measure: Overall survival (OS)
timeFrame: From the date of first dose of study drug to any-cause death, assessed up to 5 years
measure: The number of subjects experiencing adverse event TEAEs
timeFrame: up to 2 years
measure: Pharmacokinetic parameter: Maximum concentration (Cmax)
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Time to Cmax (tmax)
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Terminal half-life (t1/2)
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Area under the concentration-time curve from zero extrapolated to infinity [AUC(0-inf)]
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Area under the concentration-time curve from zero to the last quantifiable concentration [AUC(0-last)]
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Terminal rate constant (λz)
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Systemic clearance (CL)
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Volume of distribution (Vz)
timeFrame: At the end of Cycle 1 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Volume of distribution at steady state (Vss)
timeFrame: At the end of Cycle 3 (each cycle is 42 days)
measure: Pharmacokinetic parameter: Trough concentration (Ctrough)
timeFrame: At the end of Cycle 3 (each cycle is 42 days)
Other outcomes:
Locations:
Study officials:
References: