Clinical Drug Experience Knowledgebase

Criteria

For the additional cohort to the Phase II part, screening tests will be performed to identify CMS 1 or 4 and MSS before obtaining informed consent.

Patients, who meet all of the following inclusion criteria and none of the exclusion criteria, are eligible for enrollment in the study.

Inclusion Criteria

Patients who personally provided written consent to be the subjects of the study
Age of 20 years or older on the day of informed consent

[Phase Ib] Histologically confirmed gastrointestinal cancer

[Phase II] Histologically confirmed colon or rectal cancer that is adenocarcinoma , and identification of at least the KRAS codon 12 and 13 mutation status determined by RAS gene testing. Confirmation of the microsatellite instability (MSI) status.

[Additional cohort to the Phase II part] Histologically confirmed colon or rectal cancer that is adenocarcinoma, and identification of RAS mutation status. Identification of CMS 1 or 4 and MSS by screening tests.

[Phase Ib] Gastrointestinal cancer not responded to or intolerant of standard chemotherapy

[Phase II]A history of treatment with one or more regimens of the following standard chemotherapies for metastatic CRC, and being not responded to or tolerated the chemotherapies

[Additional cohort to the Phase II part] In accordance with Cohort B in the Phase II part.

Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
Patients with evaluable lesions (Cohort A in Phase II and Phase Ib) or measurable lesions (Cohort B in Phase II and the additional cohort to the Phase II part) specified in the RECIST version 1.1
Patients with adequate organ function based on the following laboratory values measured within 7 days before enrollment
Women of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients who consent to practice appropriate contraception during the study and for 4 months after the discontinuation of the protocol treatment
Patients with an expected survival of at least 3 months

Exclusion criteria

Patients who received chemotherapy, molecular-targeted agents and/or palliative radiotherapy within 2 weeks before the start of the protocol treatment or have not recovered from toxicity caused by previous treatment
Patients who underwent general anesthesia, surgery requiring hospitalization and extensive radiotherapy within 4 weeks before the start of the protocol treatment or minor surgery such as implantation of a central venous access device within two weeks before the start of the protocol treatment
Patients with active central nervous system metastases or carcinomatous meningitis.
Pregnant or lactating women
Patients who are unable or not willing to take BBI608 capsules every day
Patients with gastrointestinal disease markedly interfering with the absorption of oral formulations as judged by the investigator
Patients with active autoimmune disease requiring systemic treatment within 2 years before the start of the protocol treatment.
Patients with a history or signs of interstitial lung disease or active non-infectious pneumonitis
Patients who underwent organ or bone marrow transplantation
Patients who received a live vaccine within 30 days before the start of the protocol treatment
Patients who participated in another clinical study within 4 weeks before the start of the protocol treatment and used or using an investigational drug or device
Patients who previously received immunotherapy with drugs targeting PD-1, PD-L1 and/or PD-L2 or BBI608 therapy, or took part in a clinical study of pembrolizumab or BBI608
Patients with uncontrollable complications
Patients with a history of other malignancies within 3 years before the start of the protocol treatment.
Patients with clinically significant Electrocardiogram (ECG) abnormalities
Patients with a history of Human Immunodeficiency Virus (HIV)
Patients with active hepatitis B or C