A Study of A166 in Patients With HER2-Positive Unresectab... | NCT07299825

Studies
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

NCT07299825

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

May 8, 2026Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Her 2 Positive Breast Cancer

Interventions

A166

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2024Actual

Primary Completion Date

Sep 20, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Dec 3, 2025

First Submission Date that Met QC Criteria

Dec 17, 2025

First Posted Date

Dec 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates

Detailed Description

This study will evaluate the efficacy of A166 in patients with HER2-positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates.

A166 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A166	Experimental	A166 is administered intravenously at a dose of 4.8 mg/kg every 21 (±3) days (q3w).	Drug: A166

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A166	Drug	intravenous(IV) infusion (Q3W)	A166

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate(ORR)	ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by investigator per RECIST 1.1	Within 24 months of last patient enrolled

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	PFS, 6-month PFS, 12-month PFS.PFS as assessed by investigator according to RECIST v 1.1	Within 24 months of last patient enrolled
Overall survival (OS)	OS, 1-year survival rate, 1.5-year survival rate, and 2-year survival rate.OS defined as time from inclusion until death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.
Breast cancer patients by histopathology and/or cytology documented.
In the advanced or metastatic stage, having received no more than 5 lines of systemic therapy, one of which must include a HER2 ADC with a topoisomerase inhibitor payload.
Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.
At least one measurable lesion according to RECIST 1.1 criteria.

Exclusion Criteria:

Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.
Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components.
Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.
Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.
Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.
Other conditions considered by the investigator to make the patient unsuitable for participation in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Min Yan, Professor	Contact	0371-65588404		ym200678@126.com

Facility	Status	City	State	ZIP	Country	Contacts
Henan Provincial Cancer Hospital	Recruiting	Zhenzhou	Henan	450000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided