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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
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.
This Phase 2b, randomized, open-label, multicenter study will enroll participants with advanced MSS or mismatch repair-proficient (pMMR) colorectal cancer who have progressed on, or shown intolerance to, standard therapies, including fluoropyrimidine, irinotecan, oxaliplatin, trifluridine/tipiracil (Lonsurf), bevacizumab, and epidermal growth factor receptor (EGFR) inhibitors if RAS wild-type. Participants with BRAF V600E mutation, HER2 amplification/overexpression, KRAS G12C mutation, RET fusion, or NTRK fusion may also have received one prior targeted therapy. Prior treatment with fruquintinib or regorafenib is not allowed. Participants will be randomized 1:1 into two arms: Group A (Experimental): DSP107 10 mg/kg intravenously on Days 1, 8, and 15 of each 28-day cycle, administered after atezolizumab 1680 mg IV on Day 1 of each cycle. DSP107 infusion may be shortened after initial tolerance. Atezolizumab infusion may be shortened from 60 to 30 minutes if well tolerated. Group B (Active Comparator): Fruquintinib 5 mg orally once daily on Days 1-21 of each 28-day cycle, with dosing diaries maintained by participants. Total duration of study participation for each participant will vary based on factors including treatment tolerability, disease progression and other study discontinuation criteria. Study duration for participants will include at least: * Screening Period of up to 28 days * Treatment Period of up to 24 cycles of 28 days * Safety Follow-up Period of up to 90 days\* from the last dose of IP or active comparator.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Colarodo Cancer Center
Aurora, Colorado, United States
Mayo Clinic
Florida City, Florida, United States
Duke Cancer Institute - Duke Cancer Center
Durham, North Carolina, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Texas City, Texas, United States
The Queen Elizabeth Hospital
Woodville, Adelaide, Australia
Chris O'brien Lifehouse
Camperdown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Icon Cancer Centre
South Brisbane, Queensland, Australia
Flinders Medical Centre SA
Bedford Park, South Australia, Australia
Start Date
January 20, 2026
Primary Completion Date
September 30, 2026
Completion Date
April 30, 2027
Last Updated
February 3, 2026
90
ESTIMATED participants
DSP107 + Atezolizumab
DRUG
Fruquintinib
DRUG
Lead Sponsor
Kahr Bio Australia Pty Ltd
Collaborators
NCT04704661
NCT06696768
Data Source & Attribution
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