Overview

This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK157D1 for injection in advanced solid tumors.

Eligibility

Inclusion Criteria:

1. Be able to understand and voluntarily sign the written informed consent form.
2. Aged of ≥ 18 years and ≤75 years.
3. Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
4. At least one measurable lesion according to RECIST v1.1.
5. ECOG PS 0 or 1.
6. The expected lifespan is ≥3 months.
7. Have sufficient organ function.
8. Females participants must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.

Exclusion Criteria:

1. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
2. Having other active malignancies within 3 years.
3. Having received major surgical operations within 4 weeks before the first administration.
4. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
5. Participants with a history of mental illness and incapacitated or limited capacity.
6. Having received systemic anti-tumor treatment within 3 weeks.
7. Having received any treatment targeting B7H3.
8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
9. Previous history of severe hypersensitivity reactions.
10. Participants with active autoimmune diseases requiring systemic treatment within 2 years.
11. Known to be positive for HIV and other infections.
12. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
13. Live attenuated vaccines were received within 4 weeks.
14. Currently participating in another interventional clinical study.
15. Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.