AK157D1 injection for advanced solid tumors

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 1, first-in-human trial of AK157D1 for injection in patients with advanced solid tumors that have progressed after standard treatment or for whom no standard options exist. The study aims to assess safety, tolerability, pharmacokinetics, and immunogenicity, with exploratory measures of preliminary antitumor activity. Eligible participants have measurable disease, good performance status (ECOG 0-1), and sufficient organ function, and may undergo multiple dose-escalation cohorts to determine a recommended dose. Key exclusions include active CNS metastases, recent major surgery, and other active cancers within the past three years. The trial is sponsored by Akeso and conducted at three tertiary cancer centers in China.

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. 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.

Where it's running

• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Not yet recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Not yet recruiting

Study contacts

• Study coordinator: Zhifang Yao, M.D.
• Email: clinicaltrails@akesobio.com
• Phone: +86-0760-89873999

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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.