This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Intravenous repeating dose
Incidence and nature of dose-limiting toxicities
Time frame: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
Change in vital signs
Time frame: Through study completion or early study discontinuation
Incidence and severity of infusion reactions
Time frame: Through study completion or early study discontinuation
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