Actively Recruiting
A Randomized, Open-label, Phase 2b Study Comparing DSP107 with Atezolizumab Versus Fruquintinib in Advanced Microsatellite Stable Colorectal Cancer
Led by Kahr Bio Australia Pty Ltd · Updated on 2026-06-08
90
Participants Needed
17
Research Sites
30 weeks
Total Duration
On this page
Sponsors
K
Kahr Bio Australia Pty Ltd
Lead Sponsor
N
Novotech (Australia) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new medicine combination of DSP107 and atezolizumab compared to an existing treatment called fruquintinib for people with advanced microsatellite stable colorectal cancer. This Phase 2b study focuses on patients whose cancer has progressed despite standard therapies or who cannot tolerate those treatments. The goal is to see if the new combination offers better outcomes and safety than the current treatment options. Participants will be randomly divided into two groups. One group will receive DSP107 intravenously on Days 1, 8, and 15 of each 28-day cycle, along with atezolizumab given intravenously on Day 1 of each cycle. The other group will take oral fruquintinib once daily for 21 days in each 28-day cycle. Treatment may continue up to 24 cycles depending on how well participants tolerate it and their disease status. The study includes a screening period, treatment period, safety follow-up of up to 90 days after the last dose, and a long-term follow-up for up to 5 years. During the study, participants will undergo assessments to monitor cancer response, safety through adverse event tracking, heart function via ECGs, blood pressure, pulse rate, and quality of life. Researchers will also evaluate how the body processes the medications and immune response to DSP107 with atezolizumab. Total participation time varies based on individual treatment response and tolerability, with survival followed regularly for up to five years after randomization.
CONDITIONS
Brief Title
A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with a life expectancy greater than 3 months
- Diagnosed with inoperable, microsatellite stable (MSS) or mismatch repair proficient (pMMR) colorectal cancer
- Cancer has progressed after or is intolerant to specified prior therapies, with no more than 3 prior treatment lines
- Measurable disease according to RECIST v1.1 criteria
You will not qualify if you...
- Presence of central nervous system metastases unless stable for 2 months after definitive therapy with steroids
- Unresolved Grade 2 or higher adverse events from previous cancer treatments
- History or current diagnosis of autoimmune disease or immune deficiency
- Diagnosis of another malignancy within 3 years before starting study treatment
- Recent or current treatment with certain anticancer drugs, CYP3A4 modulators, or immunomodulating therapies (except prior checkpoint inhibitors)
- Known allergy or sensitivity to study drugs or related materials
- Clinically significant abnormal laboratory safety test results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles of 28 days each
Participants receive either DSP107 combined with atezolizumab intravenously on Days 1, 8, and 15, with atezolizumab given on Day 1 of each 28-day cycle, or fruquintinib orally once daily on Days 1-21 of each 28-day cycle. Treatment continues for up to 24 cycles or until disease progression, unacceptable toxicity, or withdrawal.
Multiple visits each cycle for DSP107 and atezolizumab infusions; daily oral dosing for fruquintinib with dosing diaries
Duration - Up to 90 days from last dose
Participants are monitored for safety and adverse events after the last dose of study treatment.
1 to 2 visits depending on safety assessments
Duration - Up to 5 years
Participants are observed for overall survival and health status for up to 5 years from randomization.
Follow-up visits approximately every 4 months
Trial Site Locations
Total: 17 locations
1
University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Colorado Cancer Center - Highlands Ranch Hospital
Highlands Ranch, Colorado, United States, 80129
Actively Recruiting
3
Mayo Clinic
Florida City, Florida, United States, 32224
Actively Recruiting
4
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
5
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
6
The University of Texas MD Anderson Cancer Center
Texas City, Texas, United States, 77030
Actively Recruiting
7
The Queen Elizabeth Hospital
Woodville, Adelaide, Australia, 5011
Actively Recruiting
8
Chris O'brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
9
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
10
Icon Cancer Centre
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
11
Flinders Medical Centre SA
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
12
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
13
Footscray Hospital - Western Health
Footscray, Victoria, Australia, 3011
Actively Recruiting
14
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
15
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
16
Sunshine Hospital - Western Health
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
17
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
A
Adam Foley Comer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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