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Special Combination of BBI608 and Pembrolizumab | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Special Combination of BBI608 and Pembrolizumab

A Phase Ib/II Study of BBI608 in Combination With Pembrolizumab in Patients With Metastatic Colorectal Cancer

NCT02851004•Takayuki Yoshino

View on ClinicalTrials.gov

Summary

the efficacy and safety of BBI608 in combination with pembrolizumab

Detailed Description

This is a multicenter, open-label Phase Ib/II study to exploratively evaluate the efficacy and safety of BBI608 in combination with pembrolizumab in patients with metastatic colorectal cancer (CRC) not responded to or intolerant of standard chemotherapy.The same analysis will be performed for the additional cohort to the Phase II part, consisting of patients with metastatic CMS 1 or 4, MMS, CRC not responsive to or intolerant of standard chemotherapy.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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.
•1. Patients who personally provided written consent to be the subjects of the study
•2. Age of 20 years or older on the day of informed consent
•3. \[Phase Ib\] 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.
•4. \[Phase Ib\] 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.
•5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
+4 more criteria

Exclusion Criteria

•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
+7 more criteria

Locations (1)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Key Dates

Start Date

October 1, 2016

Primary Completion Date

February 3, 2020

Completion Date

August 23, 2021

Last Updated

September 5, 2021

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Napabucasin

DRUG

Pembrolizumab

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Special Combination of BBI608 and Pembrolizumab

Inclusion Criteria

Exclusion Criteria

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