ARX788 in HER2-positive Metastatic Breast Cancer Patients

Phase 2

Not yet recruiting

• Conditions: HER2-positive, Metastatic Breast Cancer
• Interventions: Drug: ARX788

• Registration Number: NCT06663748
• Lead Sponsor: Henan Cancer Hospital

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Study Start: 2024-11-20
• Primary Completion: 2025-11-20
• Study Completion: 2029-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARX788	ARX788	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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: Terminal half-life (t1/2)	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)
The number of subjects experiencing adverse event TEAEs	up to 2 years	Number of participants with TEAEs as assessed by CTCAE v5.0
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.