A Study of AK146D1 for Injection in the Treatment of Advanced Solid Tumors

Launched by AKESO · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called AK146D1 for people with advanced solid tumors, which are types of cancer that have spread and cannot be removed by surgery. This study is in the early phase, meaning it's the first time this treatment is being tested in humans. The main goals are to see how safe the treatment is, how well it works, and how it affects the body. The trial is not yet recruiting participants, but it is looking for adults aged 18 to 75 who have advanced tumors that have either progressed despite previous treatment or where no standard treatment options are available.

To be eligible for this trial, participants need to be able to understand and sign a consent form, have a confirmed diagnosis of advanced cancer, and show that they have at least one measurable tumor. People with other active cancers, certain serious health conditions, or recent treatments may not qualify. If chosen to participate, individuals can expect to receive the treatment in a controlled setting where their health will be closely monitored. This trial is an important step in exploring new options for patients facing 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 or any treatment with topoisomerase I inhibitor agents.
• • 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.