A Study of AK146D1 for Injection in Advanced Solid Tumors

Launched by AKESO · Jul 13, 2025

Keywords

ClinConnect Summary

This clinical trial is a first-time study in humans to test a new medicine called AK146D1, which is being developed to treat advanced solid tumors—these are cancers that have grown large or spread and don’t respond well to current treatments. The main goals of the trial are to see if the medicine is safe, how the body processes it, whether it causes an immune response, and if it shows any early signs of helping to shrink tumors.

Adults between 18 and 75 years old with certain types of advanced solid tumors that cannot be removed by surgery and have not responded to standard treatments may be eligible. Participants should be in reasonably good health aside from their cancer, able to understand the study, and have at least one tumor that can be measured. During the study, patients will be carefully monitored for side effects and how their cancer responds. It’s important to know that people with other active cancers, certain infections, recent cancer treatments, or serious medical conditions may not be able to join. This study is currently not recruiting yet, but it aims to gather important information that could lead to new treatment options for people with difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• 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. Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
• • 6. At least one measurable lesion according to RECIST v1.1.
• • 7. Have sufficient organ function.
• • 8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception
• Exclusion Criteria:
• • 1. Having other active malignancies within 3 years.
• • 2. Currently participating in another interventional clinical study.
• • 3. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
• • 4. Having received any treatment targeting Trop2 or Nectin4.
• • 5. Having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration.
• • 6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 5.0 grade 1 or lower.
• • 7. Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks.
• • 8. Subjects with active autoimmune diseases requiring systemic treatment within 2 years.
• • 9. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
• • 10. Known to be positive for HIV and other infections.
• • 11. Previous history of severe hypersensitivity reactions.
• • 12. Live attenuated vaccines were received within 4 weeks.
• • 13. Subjects with a history of mental illness and incapacitated or limited capacity.
• • 14. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.