A phase I/II, open label, multi-centre study to assess the safety, tolerability, and efficacy of MG010 in combination with sorafenib in subjects with solid tumours who have failed existing treatments.

ACTRN 12620000849998

Brief Summary

This purpose of this study is to determine the safety, tolerability and efficacy of MG010 in combination with sorafenib in patients with solid tumors who have failed existing treatments

Intervention/Treatment

• Drug: Sorafenib.
• Drug: MG010.

Inclusion Criteria

1. Age over 18 years.
2. For subject to be enrolled in cohort 1 of dose-escalation stage:
   • Histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of advancedat a late stage, far along or metastatic solid tumors for which standard treatment is unavailable/ineffective/intolerable.
3. For subject to be enrolled in additional cohorts of dose- escalation stage and dosethe amount of medication taken expansion cohort:
   • Histologically confirmed diagnosis of one of the following advanced or metastatic solid tumours for which standard treatment is unavailable/ineffective/intolerable:
     • Non-small cell lung carcinomacancer arising from tissues that line organs.
     • Renal cell carcinoma.
     • Colorectalrelating to the colon or rectum in the large bowel/intestine cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs, or
     • Hepatocellular carcinoma with liver function of Child-Pugh Class A or B (score 7 only), who are resistant to sorafenib.
4. Disease progression within 6 months after most recent standard therapy.
5. ECOG performance status of less than or equal to 2.
6. Have at least one tumoura tissue mass that forms from groups of unhealthy cells lesion measurable in a unidimensional way with either spiral CT/PET or CT or MRI (in case of brain lesions) only according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
7. Adequate organ function within 14 days prior to enrolment, as defined below:
   • Bilirubin less than or equal to x Upper Normal Limit (UNL).
   • AST/ALT/ALP < 5 x UNL.
   • Polynuclear neutrophilsa type of white blood cell that act as a first responder to infections in the body greater than or equal to 1 500/mm^3.
   • Haemoglobin > 90g/L.
   • Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding greater than or equal to 100 000/mm^3.
   • Serum Creatinine < 2 x UNL.
   • GFR > 30 mL/min.
8. Adequate oral intake without the need for enteral or parenteral feeding.
9. Life expectancy > 3 months.
10. Ability to understand and willing to sign a written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. document and to comply with the study protocol.
11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, during the last study period and for the following 6 months after the last study drug intake. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
12. No known or suspected allergy or hypersensitivity to sorafenib or any component of the excipients of MG010.
13. For subjects with evidence of chronica long-lasting disease that changes slowly over time hepatitis B virus (HBV) infectiona condition where harmful pathogens, such as bacteria, viruses or parasites, have entered the body, the HBV viral load must be undetectable on suppressive therapy, if indicated.
14. Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured. For subjects with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.