A Phase 1 Study of ARQ 197 in Patients With Solid Tumors

A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors

This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Inclusion Criteria:

• Patients who did not respond or are refractory to available therapy or for whom no standard effective systemic therapy exists.
• Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Patients with adequate organ function

Exclusion Criteria:

• Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of ARQ 197
• Known symptomatic brain metastases
• Pregnant or breastfeeding
• Uncontrolled intercurrent illness