Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

Inclusion Criteria:

• Participant is NOT eligible for other clinical trials currently open in the region
• Participant has failed or progressed on standard of care systemic therapy
• FOLFIRI (with or without 5FU bolus and continuous infusion)/bevacizumab plusonvansertib is appropriate for the participant as determined by the treatingphysician, including participants who have previously been treated with FOLFIRI
• Histologically confirmed metastatic and unresectable CRC with a confirmed KRASmutation
• Age ≥ 18 years
• Participant was previously enrolled in an existing Cardiff clinical trial that isending and based on investigator judgement has responded to treatment usingonvansertib plus FOLFIRI (with or without 5FU bolus) + bevacizumab Women of Child-bearing Potential
• Women of child-bearing potential (WOCBP) must agree to use method(s) of contraception
• WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/Lor equivalent units of human chorionic gonadotropin) within 24 hours prior to thestart of onvansertib treatment
• If sexually active, the participant must agree to use contraception consideredadequate and appropriate by the treating physician during the period of onvansertibadministration

Exclusion Criteria:

• Participant has not recovered from minor or major surgery and less than 6 weeks outfrom major surgery
• Participant has active Hepatitis B or C infection
• Participant has a known history of testing positive for human immunodeficiency virusor having been diagnosed with acquired immunodeficiency syndrome
• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, clinically significant non-healing or healing wounds, symptomaticcongestive heart failure Class II or higher according to the New York HeartAssociation Functional Classification, unstable angina pectoris, significant pulmonarydisease (shortness of breath at rest or mild exertion), that would limit compliancewith study requirements
• Abnormal glucuronidation of bilirubin, known Gilbert's syndrome
• Participants with any other serious or uncontrolled medical disorder, activeinfection, physical exam finding, laboratory finding, altered mental status, orpsychiatric condition that, in the opinion of the treating physician, wouldsubstantially increase risk to their well-being
• Any condition that, in the opinion of the treating physician, would substantiallyincrease risk to their well-being