Advanced Tumors Clinical Trial
Official title:
A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors
This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 3 + 3 study design to identify the maximum tolerated dose (MTD).
Primary Objectives: • To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-100 as once every two weeks (Q2W) and once every three weeks (Q3W) regimens in patients with advanced tumors Secondary Objectives: - To evaluate the pharmacokinetics (PK) of CPI-100 - To evaluate clinical response and resolution of symptoms after CPI-100 treatment - To characterize adverse events of CPI-100 monotherapy and CPI-100 in combination with capecitabine in patients with advanced cancers Up to 5 dose levels of CPI-100 Q2W, 4 dose levels of Q3W regimen of CPI-100 monotherapy (Q3W Arm A) and 4 dose levels of Q3W regimen of CPI-100 in combination with capecitabine (Q3W Arm B) will be tested in a dose escalation study. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-100 within 28 days (Q2W) or 42 days (Q3W): - Grade 4 or greater treatment related adverse events - Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours) ;
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