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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
University of Colarodo Cancer Center
NOT_YET_RECRUITING
Aurora
Florida
Mayo Clinic
NOT_YET_RECRUITING
Florida City
North Carolina
Duke University Medical Center - Duke Cancer Center
RECRUITING
Durham
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Texas
The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Texas City
Other Locations
Australia
Flinders Medical Centre SA
RECRUITING
Bedford Park
Chris O'brien Lifehouse
RECRUITING
Camperdown
Monash Health
RECRUITING
Clayton
Footscray Hospital - Western Health
RECRUITING
Footscray
Austin Health
RECRUITING
Heidelberg
Alfred Hospital
RECRUITING
Melbourne
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
Sunshine Hospital - Western Health
RECRUITING
Saint Albans
Icon Cancer Centre
RECRUITING
South Brisbane
Westmead Hospital
RECRUITING
Westmead
The Queen Elizabeth Hospital
RECRUITING
Woodville
Contact Information
Primary
Adam Foley Comer
adam@kahrbio.com
+972 54 749 1753
Time Frame
Start Date:2026-01-16
Estimated Completion Date:2027-04-30
Participants
Target number of participants:90
Treatments
Experimental: DSP107 in combination with Atezolizumab
DSP107 10 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle. Atezolizumab 1680 mg IV on Day 1 of each 28-day cycle.
Active_comparator: Fruquintinib
Participants will receive fruquintinib orally in 28-day cycles, for up to 24 cycles (96 weeks), or until disease progression, unacceptable toxicity, or study withdrawal.