AK146D1 plus AK112 in advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II interventional trial evaluating the combination of AK146D1 and AK112 in patients with advanced breast cancer. The study will monitor safety, tolerability, antitumor activity, pharmacokinetics, and immunogenicity. Eligible participants have HER2-negative, locally advanced, recurrent, or metastatic disease with measurable lesions and adequate organ function. Treatment cycles, dosing, and study procedures will be described in the protocol, with outcomes assessed by standard criteria and follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be able to understand and voluntarily sign the written informed consent form.
2. Aged of ≥ 18 years and ≤75 years.
3. ECOG PS 0 or 1.
4. The expected lifespan is ≥3 months.
5. Patients with histologically confirmed locally advanced, recurrent, or metastatic breast cancer who are not eligible for curative surgical resection; and who have histologically or cytologically confirmed HER2-negative disease.
6. At least one measurable lesion according to RECIST v1.1. Patients with only bone lesions or cutaneous lesions are not ineligible for enrollment.
7. Have sufficient organ function.
8. Females patients must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.

Exclusion Criteria:

1. Patients had breast cancer amenable to curative treatment at study enrollment.
2. Concurrent other histopathological types confirmed by tumor histology or cytology.
3. Having other active malignancies within 3 years.
4. Currently participating in another interventional clinical study.
5. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
6. Prior treatment with any therapy targeting Trop-2 or Nectin-4, or any chemotherapy agent targeting topoisomerase I.
7. Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks prior to the first dose.
8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
9. Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.
10. Patients with active autoimmune diseases requiring systemic treatment within 2 years.
11. Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.
12. Known to be positive for HIV and other infections.
13. Previous history of severe hypersensitivity reactions.
14. Live attenuated vaccines were received within 4 weeks.
15. Patients with a history of mental illness and incapacitated or limited capacity.
16. Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Ting Liu
• Email: clinicaltrials@akesobio.com
• Phone: +86(0760)8987 3999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.