A Phase Ib/II Study of Atamparib in Patients With Advanced Solid Tumors
This is a multi-part, open-label, non-randomized phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of atamparib, an investigational agent, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) adenocarcinoma. The study comprises dose escalation (phase Ib) and expansion (phase II).
• Subject must be ≥18 years of age.
• Histologically confirmed diagnosis of unresectable advanced or metastatic NSCLC adenocarcinoma.
• Documented KRAS mutation status at study entry.
• Have received at least one line of standard therapy and experienced radiographic tumor progression to the last administered treatment and have failed institutional standards of care.
• Have measurable tumor lesions
• ECOG 0-1
• Adequate organ functions