A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)

Key Inclusion Criteria:

• Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectumwith at least one measurable lesion according to RECIST v1.

• Genetic aberrations are allowed, except for microsatellite instability high (MSI-H)and BRAF V600

• Participants must have received first-line therapy for mCRC that includedoxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEVregimes are not permitted. A minimum of 2 cycles of first line of therapy must havebeen completed.

• At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2

Key Exclusion Criteria:

• Current treatment with other anticancer treatments within 21 days of the first doseof study treatment

• Major surgery within 4 weeks of the first planned dose of study treatment

• More than one prior systemic treatment for mCRC or any prior systemic treatmentincluding FOLFIRI or irinotecan-based therapy.

• Participants who received oxaliplatin and fluoropyrimidine in the first lineneoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressedwithin 6 months are not eligible due to lack of BEV exposure.

• Uncontrolled, symptomatic brain metastases

• Uncontrolled, symptomatic gastrointestinal disease

• Participants with uncontrolled hypertension

• Women who are pregnant, nursing, or plan to become pregnant while in the study andfor at least 6 months after the last administration of study chemotherapy

• Men who plan to father a child while in the study and for at least 6 months afterthe last administration of study chemotherapy

• Documented major electrocardiogram (ECG) abnormalities which are clinicallysignificant.

• Symptomatic or uncontrolled brain metastases, spinal cord compression, orleptomeningeal disease requiring concurrent treatment

• Presence of other active invasive cancers other than the one treated in this studywithin 5 years prior to screening