A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.
Recruiting · NCT07235293 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
DSP107 + AtezolizumabFruquintinib
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
18 locations listed across 5 US states.
- University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP) - Aurora, Colorado, United States
- University of Colorado Cancer Center - Highlands Ranch Hospital - Highlands Ranch, Colorado, United States
- Mayo Clinic - Florida City, Florida, United States
- Duke University Medical Center - 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
- Port Macquarie Base Hospital (Mid North Coast Cancer Institute), Wrights Road, - Port Macquarie, 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
- Monash Health - Clayton, Victoria, Australia
- Footscray Hospital - Western Health - Footscray, Victoria, Australia
- Austin Health - Heidelberg, Victoria, Australia
- Alfred Hospital - Melbourne, Victoria, Australia
- Sunshine Hospital - Western Health - Saint Albans, Victoria, Australia
- Sir Charles Gairdner Hospital - Nedlands, Western Australia, Australia