A Dose Finding and Safety Study of Oral LEQ506 in Patients With Advanced Solid Tumors

A Phase I, Multi-center, Open Label, Dose Escalation Study of LEQ506, an Oral Smoothened Inhibitor, in Patients With Advanced Solid Tumors

This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LEQ506 given orally on a daily dosing schedule in patients with advanced solid tumors.

Inclusion Criteria:

• Confirmed diagnosis of advanced solid tumor, recurrent or refractory medulloblastoma or locally advanced or metastatic basal cell carcinoma)
• Protocol defined laboratory parameters
• Performance status ≤ 2
• Patients must have fully recovered from the prior effects of major surgery and from any acute toxicities of prior chemotherapy/radiotherapy

Exclusion Criteria:

• History of central nervous system tumors of symptomatic brain metastases (excludes medulloblastoma patients)
• Impairment of gastrointestinal function or unresolved nausea, vomiting or diarrhea
• Impairment of cardiac function or significant cardiac disease
• Pregnant or lactating women
• Other protocol-defined inclusion/exclusion criteria may apply