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