A Phase Ib/II Study of BBI608 in Combination with Pembrolizumab in Patients with Metastatic Colorectal Cancer
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000023149
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 95
Not provided
1. 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 2. 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 3. Patients with active central nervous system metastases or carcinomatous meningitis. 4. Pregnant or lactating women 5. Patients who are unable or not willing to take BBI608 capsules every day 6. Patients with gastrointestinal disease markedly interfering with the absorption of oral formulations as judged by the investigator 7. Patients with active autoimmune disease requiring systemic treatment within 2 years before the start of the protocol treatment. 8. Patients with a history or signs of interstitial lung disease or active non-infectious pneumonitis 9. Patients who underwent organ or bone marrow transplantation 10. Patients who received a live vaccine within 30 days before the start of the protocol treatment 11. 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 12. 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 13. Patients with uncontrollable complications 14. Patients with a history of other malignancies within 3 years before the start of the protocol treatment. 15. Patients with clinically significant ECG abnormalities 16. Patients with a history of HIV 17. Patients with active hepatitis B or C
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immune-related objective response rate (irORR) determined by their Response Evaluation Criteria In Solid Tumors (irRECIST) [Additional cohort to the Phase II part] Objective response rate determined by the RECIST version 1.1
- Secondary Outcome Measures
Name Time Method Immune-related progression free survival (irPFS) rate at Week 12 determined by the irRECIST Objective response rate determined by the RECIST version 1.1 Progression free survival rate at Week 12 determined by the RECIST version 1.1 PFS Overall survival Disease control rate Incidence of adverse events Pharmacokinetic parameters [Additional cohort to the Phase II part] Immune-related objective response rate by irRECIST Progression free survival, Overall Survival, Disease Control Rate The incidence of adverse events