Brief Summary
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK146D1 for injection in advancedat a late stage, far along solid tumors.
Intervention/Treatment
- Drug: AK146D1 for injection
Inclusion Criteria
- Be able to understand and voluntarily sign the written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. form.
- Aged of ≥ 18 years and ≤75 years.
- ECOG PS 0 or 1.
- The expected lifespan is ≥3 months.
- Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
- At least one measurable lesion according to RECIST v1.1.
- Have sufficient organ function.
- Females subjects must not be pregnant at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception.