Study of JK06 in Patients With Unresectable Locally Advanced or Metastatic Cancer
Trial Parameters
Brief Summary
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered JK06 in patients with unresectable locally, advanced or metastatic cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Signed informed consent and willing and able to comply with study procedures and scheduled visits. 3. For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors. 4. Dose expansion solid tumor groups. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 6. Life expectancy ≥ 12 weeks. 7. Measurable disease as per RECIST 1.1 criteria and documented by CT and/or MRI. Note: lesions treated previously with radiation must demonstrate clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrollment. 8. Acceptable laboratory parameters: * Albumin ≥ 2.8 g/dL. * Platelet count ≥ 100, 000. * Hemoglobin ≥ 9.0 g/dL. * Absolute neutrophil count ≥ 1,500/μL. * ALT/AST ≤ 3.0 times ULN. \- ALT/AST ≤ 5 × ULN for patients with liver metastases. * Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease. * Direct biliru