About this trial
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.
Eligibility criteria
Qualifiers
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).
Measurable disease per RECIST v1.1.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DSP107 + Atezolizumab
- Fruquintinib
Treatment groups
Sponsors and collaborators
Kahr Bio Australia Pty Ltd
Lead sponsor
Novotech (Australia) Pty Limited
Collaborator