A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.
A Randomized, Open-label, Phase 2b Study to Compare the Efficacy of DSP107 in Combination With Atezolizumab Versus Fruquintinib in Patients With Advanced Microsatellite Stable Colorectal Cancer
Kahr Bio Australia Pty Ltd
90 participants
Jan 20, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria7
- 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.
- Clinically significant abnormal laboratory safety tests.
Interventions
DSP107 infusion begins \~30 (±10) minutes after completion of atezolizumab infusion on Day 1.
5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT07235293