Clinical trial · Interventional
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Phase 2 Study of A166 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With TOP1-ADCs
NCT07299825CI-TRIAL-00110890recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Her 2 Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A166 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A166
- description
- A166 is administered intravenously at a dose of 4.8 mg/kg every 21 (±3) days (q3w).
- interventionNames
- Drug: A166
Primary outcomes (1)
- measure
- Objective response rate(ORR)
- timeFrame
- Within 24 months of last patient enrolled
- description
- 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
Secondary outcomes (5)
- measure
- Progression-free survival (PFS)
- timeFrame
- Within 24 months of last patient enrolled
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form. 2. Breast cancer patients by histopathology and/or cytology documented. 3. 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. 4. Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization. 5. At least one measurable lesion according to RECIST 1.1 criteria. Exclusion Criteria: 1. Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload. 2. Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 or their components. 3. Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments. 4. Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses. 5. Presence of spinal cord compression or clinically active central nervous system (CNS) metastases. 6. Other conditions considered by the investigator to make the patient unsuitable for participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.