AN OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND EXPANSION PHASE IB STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, ANDTHERAPEUTIC ACTIVITY OF RO6958688 IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED AND/OR METASTATIC CEA-POSITIVE SOLID

Protocol: 
AAAR1902
Phase: 
I

AN OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND EXPANSION PHASE IB STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, ANDTHERAPEUTIC ACTIVITY OF RO6958688 IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED AND/OR METASTATIC CEA-POSITIVE SOLID

The purpose of this study is to find out, as a main objective, at which doses RO6958688 (study drug) can be administered safely to subjects in combination with atezolizumab (study drug), and what the side effects are when both drugs are given together. Additionally, the effects of RO6958688 and atezolizumab in the body, and particularly in the tumor, will be evaluated. The study also aims to find out if RO6958688 in combination with atezolizumab can slow down the growth of tumors or stop the cancer, in subjects with locally advanced and/or metastatic solid tumors. This study is for subjects whose tumor’s cells express the carcinoembryonic antigen (CEA), which is the target of RO6958688. RO6958688 and atezolizumab (study drugs) are investigational new drugs being studied by F. Hoffmann-La Roche Ltd (Sponsor) and Columbia University Medical Center (under the direction of Dr. Gulam Manji and the research staff) for treating solid tumors that express carcinoembryonic antigen. RO6958688 and atezolizumab will be given free of charge to participants in this study.

Are you Eligible? (Inclusion Criteria)

Subjects must meet the following criteria for study entry:
1. Signed informed consent
2. Age ≥ 18 years
3. Confirmed locally advanced and/or metastatic solid tumor, with at least
one tumor lesion of accessible non-critical location to biopsy, in patients
who have progressed on a standard therapy, are intolerant to standard
therapy, and/or are non-amenable to standard therapy
4. Radiologically measurable and clinically evaluable disease (as per RECIST
v1.1 - previously irradiated lesions should not be counted as target
lesions)
5. Life expectancy (in the opinion of the investigator) of ≥ 12 weeks
ovulation, symptothermal, or postovulation methods) and withdrawal are not
acceptable methods of contraception.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States