What this study is
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.
What's being tested
- DSP107 + Atezolizumab
Intervention · DRUG
DSP107 infusion begins ~30 (±10) minutes after completion of atezolizumab infusion on Day 1.
- Fruquintinib
Intervention · DRUG
5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.
Study details
- Official title
- 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
- Sponsor
- Kahr Bio Australia Pty Ltd
- Conditions
- Colorectal Cancer
- Enrolling
- 90 people
- Starts
- 2026-01-16
- Est. completion
- 2027-04-30
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (18)
18 openUniversity of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)
Aurora, Colorado, United States
- Hannah Robinson · Principal investigator
RecruitingUniversity of Colorado Cancer Center - Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
- Hannah Robinson · Principal investigator
RecruitingMayo Clinic
Florida City, Florida, United States
- Conor O'Donnell, Dr · Principal investigator
RecruitingDuke University Medical Center - Duke Cancer Center
Durham, North Carolina, United States
- Nicholas DeVito · Principal investigator
RecruitingUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
- Anwaar Saeed, MD · Principal investigator
RecruitingThe University of Texas MD Anderson Cancer Center
Texas City, Texas, United States
- Maria Pia Morelli, MD · Principal investigator
Recruiting
12 sites outside the US
The Queen Elizabeth Hospital
Woodville, Adelaide, Australia
- Timothy Jay Price, Dr · Principal investigator
RecruitingChris O'brien Lifehouse
Camperdown, New South Wales, Australia
- Sarah Isabella MacKenzie Sutherland, Dr · Principal investigator
RecruitingPort Macquarie Base Hospital (Mid North Coast Cancer Institute), Wrights Road,
Port Macquarie, New South Wales, Australia
- Dr Stephen Donald Begbie · Principal investigator
RecruitingWestmead Hospital
Westmead, New South Wales, Australia
- Adnan Mahmood Nagrial, Associate Professor · Principal investigator
RecruitingIcon Cancer Centre
South Brisbane, Queensland, Australia
- Jermaine lan George Coward, A/Prof · Principal investigator
RecruitingFlinders Medical Centre SA
Bedford Park, South Australia, Australia
- Christos Stelios Karapetis, Prof · Principal investigator
RecruitingMonash Health
Clayton, Victoria, Australia
- David Kar Wah Lau, Dr · Principal investigator
RecruitingFootscray Hospital - Western Health
Footscray, Victoria, Australia
- Peter Gibbs, Prof · Principal investigator
RecruitingAustin Health
Heidelberg, Victoria, Australia
- Niall Christopher Tebbutt, Prof · Principal investigator
RecruitingAlfred Hospital
Melbourne, Victoria, Australia
- Andrew Mark Meurisse Haydon, Dr · Principal investigator
RecruitingSunshine Hospital - Western Health
Saint Albans, Victoria, Australia
- Peter Gibbs, Prof · Principal investigator
RecruitingSir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
- Rajiv Narayan Shinde, Dr · Principal investigator
Recruiting
Study team
Sponsor
Kahr Bio Australia Pty Ltd
Study ID DSP107_003
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.