GKL-006Allo Injection in Patients With Advanced Solid Tumors

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of GKL-006Allo Injection in participants with advanced solid tumors.

This Phase 1 study will evaluate GKL-006Allo Injection in participants with advanced or metastatic solid tumors who have failed or are intolerant to standard therapy.

The study includes single-dose and multiple-dose treatment, with a potential dose-expansion stage to further evaluate selected dose level according to protocol-specified criteria. The single-dose and multiple-dose stages are designed to characterize safety, tolerability, and biological activity across protocol-specified dose levels.

Participants will receive GKL-006Allo Injection according to the study protocol and will undergo scheduled safety monitoring, tumor assessments, pharmacokinetic and pharmacodynamic sampling, and immunogenicity testing during treatment and follow-up.

Inclusion Criteria:

• Able to understand and voluntarily sign the informed consent form.
• Aged 18 to 75 years.
• Histologically, cytologically or clinical confirmed unresectable locally advanced or metastatic solid tumor that has failed standard therapy.
• At least one measurable tumor lesion during screening according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and life expectancy of at least 3 months.
• Adequate hematologic and organ function.
• Participants of childbearing potential must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after the end of study treatment.
• Able to communicate with the investigator, comply with study visits, and understand and follow study requirements.

Exclusion Criteria:

• Recently received radical radiotherapy or other anti-tumor therapy.
• Known hypersensitivity to any component of the study treatment.
• Prior history or concurrent malignancy that has not been cured.
• Active infection, known or suspected autoimmune disease.
• Last anti-tumor treatment toxicity not yet recovered to suitable status.
• Other organ dysfunction or situations deemed inappropriate by the investigator.