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A MULTI-CENTER, OPEN-LABEL, PHASE 2 STUDY TO EVALUATE SAFETY AND EFFICACY OF U3-1402 IN SUBJECTS WITH ADVANCED OR METASTATIC COLORECTAL CANCER (CRC)

Study

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Details
Age

Adult

Eligibility

Must be resistant, refractory, or intolerant to at least 2 prior lines of therapy, that must include all of the following agents: a. Fluoropyrimidine b. Irinotecan c. Platinum agents (eg, oxaliplatin) d. An anti-EGFR agent, if clinically indicated (eg, RAS/BRAF wildtype) e. An anti-VEGF agent, unless contraindicated (eg, bevacizumab) Note: Subjects with known microsatellite instability-high (MSI-H) status must have received treatment with an immune checkpoint inhibitor unless contraindicated.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Chris Lieu

Chris Lieu

Study ID

Protocol Number: 20-1267

More information available at ClinicalTrials.gov: NCT04479436

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