A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309

Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors

This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no therapy of proven efficacy is available.
• Age ≥ 18
• Evidence of tumor progression with measurable or evaluable disease.
• Use of adequate contraceptive measures for male patients.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
• Signed informed consent.

Exclusion Criteria:

• Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors)
• Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
• Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP>150/100mmHg.
• Pre-diagnosed diabetes mellitus.
• Fasting glucose > 7.0 mmol/L or HbA1c > 6%.