PHASE I STUDY OF RO6958688 +/- OTHER ANTI-CANCER AGENTS IN PATIENTS WITH ADVANCED SOLID TUMORS
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2080223708
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 36
Advanced or recurrent cancer that is refractory or ineligible to standard therapy or for which no standard therapy exists.
Histologically or cytologically confirmed solid tumor.
Confirmation of CEA-positivity at the sponsor-designated central laboratory
ECOG PS of 0 or 1.
Life expectancy >= 12 weeks from the date of enrollment.
Major organ function meets all criteria.
Pregnant or lactating woman.
Current or previous autoimmune disease.
History of adverse drug reactions that were considered to be immune-mediated, or severe as a result of cancer immunotherapy, including immune checkpoint inhibitors.
Positive test result for human immunodeficiency virus (HIV) antibody, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody (eligible if HCV-RNA-negative).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method