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Not Yet Recruiting NCT07704515

GKL-006Allo Injection in Patients With Advanced Solid Tumors

Conditions: Solid Tumor Malignancies

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 27
Sponsor: Beijing Gene Key Life Technology Co., Ltd

Location: Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality

Summary

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07704515). StuddyBuddy aggregates publicly available trial information.