NCT07299825 A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
| NCT ID | NCT07299825 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Condition | Her 2 Positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-20 |
| Primary Completion | 2027-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-09-20 with a primary completion date of 2027-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07299825 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Her 2 Positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07299825 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07299825 currently recruiting?
Yes, NCT07299825 is actively recruiting participants. Contact the research team at ym200678@126.com for enrollment information.
Where is the NCT07299825 trial being conducted?
This trial is being conducted at Zhenzhou, China.
Who is sponsoring the NCT07299825 clinical trial?
NCT07299825 is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.