Study of JK06 in Patients with Unresectable Locally Advanced or Metastatic Cancer

Inclusion Criteria:

1. Age ≥ 18 years old. 2. Signed informed consent and willing and able to complywith study procedures and scheduled visits.

2. For Dose Escalation, patients with histologically diagnosed unresectable,locally advanced, or metastatic solid tumors.

3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 5. Lifeexpectancy ≥ 12 weeks. 6. Measurable disease as per RECIST 1.1 criteria anddocumented 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.

7. 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 bilirubin ≤ 1.5 ULN for patients with total bilirubin > 1.5 ULN.

• Creatinine ≤ 1.8 mg/dL.

• Or calculated/measured creatinine clearance > 30 mL/minute. 8. Identificationof an archival tumor sample (i.e., tissue block (formalin-fixedparaffin-embedded [FFPE]) or a series of approximately 10-15 slides).

9. Consent to pre-treatment fresh tumor biopsy for patients enrolled in theback-fill part of Dose Escalation and all eligible patients enrolled inCohort Expansion.
10. Women of childbearing potential (WOCBP) not surgically sterilized andbetween menarche and 1 year post menopause must have a negative serum orurine pregnancy test.
11. Treated central nervous system (CNS) metastases 12. Must be willing andable to comply with clinic visits and procedures outlined in the studyprotocol.
12. Concurrent use of hormones for breast cancer or for non-cancer relatedconditions (e.g., insulin for diabetes, hormone replacement therapy) isacceptable. Bisphosphonates or RANK-L inhibitors or analogues arepermitted for supportive care of patients with bone metastases.

Exclusion Criteria:

1. Patients with symptomatic or unstable CNS primary tumor or metastases and/orcarcinomatous meningitis. Patients with documented treated CNS metastases stable forat least 4 weeks may be enrolled at the discretion of the investigator.

2. Major surgery within 6 weeks from treatment initiation.

3. Clinically significant cardiovascular/vascular disease ≤ 6 months before first dose.

4. Clinically significant gastrointestinal disorders.

5. Clinically significant pulmonary compromise requiring supplemental oxygen use.

6. Grade 2 or greater peripheral neuropathy at time of study entry.

7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation ofstudy drug administration. Inactivated annual influenza vaccination is allowed.

8. Known hypersensitivity to JK06 or any excipient.

9. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions includenon-melanoma skin cancer, cervical carcinoma in situ, resected melanoma in situ, orany malignancy considered to be indolent and never required therapy.

10. Any serious underlying medical or psychiatric condition that would precludeunderstanding and rendering of informed consent or impair the ability of the patientto receive or tolerate the planned treatment.

11. Recent or ongoing serious infection.

12. Prior systemic anti-cancer treatment:

• For cytotoxic chemotherapy, small molecule inhibitors, radiation, or similarinvestigational treatments, ≤ 2 weeks or 5 half-lives, whichever is shorter.

• For monoclonal antibodies or similar experimental therapies: ≤ 3 weeks or 5half-lives, whichever is shorter.

• Antibody drug conjugates and radioimmunoconjugates or other similarexperimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.

13. Ascites or pleural effusions requiring large volume para- or pleurocentesis within 4weeks of treatment initiation.

14. Pregnant or nursing.

15. Therapeutic anticoagulation for a thromboembolic event that occurred within 3 monthsof dosing; prophylactic anticoagulation is permitted.