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A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.
Trial Status: active
This clinical study is testing whether a new combination of medicines (DSP107 and
atezolizumab) is more effective and safer than an existing treatment (fruquintinib) for
people with advanced colorectal cancer that is microsatellite stable (MSS). Participants
will be randomly assigned to receive one of the two treatments, and researchers will
monitor how well the cancer responds, how safe the treatments are, and how the body
processes them. The study hopes to show that the new combination can improve outcomes for
patients with this type of colorectal cancer.
Inclusion Criteria
Are ≥ 18 years of age with a life expectancy of > 3 months.
Participants with histologically confirmed, inoperable, MSS and/or pMMR CRC which has progressed to, or is intolerant to, specified therapies (and has received prior treatment with no more than 3 lines of therapy). Note: Lines of therapy are defined by disease progression between therapies. Participants who discontinue their prior regimen due to toxicity (in the absence of disease recurrence/progression) will also have their prior therapy count as one prior regimen.
Measurable disease per RECIST v1.1.
Exclusion Criteria
Central nervous system (CNS) metastases unless stable 2 months post definitive therapy with steroids.
Unresolved AEs of Grade 2 or higher from prior anticancer therapy.
Past or current history of autoimmune disease or immune deficiency.
History of other malignancy within 3 years of first study treatment cycle.
Current or recent treatment with certain therapies including specified anticancer treatments, modulators of CYP3A4 and immunomodulating therapies (prior treatment with CPIs is not exclusory).
Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test product.
