Study on DSP107 and Atezolizumab Compared to Fruquintinib for Treating Colorectal Cancer
Sponsor: Kahr Bio Australia Pty Ltd
ClinicalTrials ID:NCT07235293
This clinical trial is exploring whether a new combination of drugs, DSP107 and atezolizumab, is more effective and safer than the existing treatment, fruquintinib, for patients with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to one of the treatments, and researchers will track how well the cancer responds and the safety of the treatments.
Patient Parameters
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Program Overview
The study aims to find out if a new combination of medicines, DSP107 and atezolizumab, can work better than the current treatment, fruquintinib, for people with advanced colorectal cancer that is microsatellite stable (MSS). Participants will be randomly assigned to receive either the new combination or fruquintinib. Researchers will monitor the cancer's response, the safety of the treatments, and how the body processes them. The goal is to see if the new combination can improve outcomes for patients with this type of colorectal cancer.
Description
This study is in Phase 2b and involves participants with advanced colorectal cancer that is microsatellite stable (MSS) or mismatch repair-proficient (pMMR). These participants have already tried standard treatments like fluoropyrimidine, irinotecan, oxaliplatin, and others, but their cancer has either progressed or they couldn't tolerate the treatments. Participants with certain genetic mutations may have also tried one targeted therapy before.
Participants will be divided into two groups:
- Group A (Experimental): Will receive DSP107 through an IV on specific days of a 28-day cycle, along with atezolizumab on the first day of each cycle. The infusion times may be shortened if tolerated well.
- Group B (Active Comparator): Will take fruquintinib orally for 21 days of each 28-day cycle, keeping a dosing diary.
The study will last different lengths for each participant, depending on how they tolerate the treatment and how their disease progresses. The study includes a screening period, a treatment period of up to 24 cycles, and a follow-up period after the last dose.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older with a life expectancy of more than 3 months.
- Have advanced colorectal cancer that cannot be operated on, is microsatellite stable (MSS) or mismatch repair-proficient (pMMR), and has not responded to or cannot tolerate certain treatments.
- Have measurable cancer according to specific medical criteria.
Exclusion Criteria
- Have cancer that has spread to the brain unless it has been stable for 2 months after treatment.
- Have unresolved side effects from previous cancer treatments that are moderate or severe.
- Have a history of autoimmune disease or immune deficiency.
- Have had another type of cancer within the last 3 years.
- Are currently or recently treated with certain medications that could interfere with the study.
- Have known allergies to any of the study drugs or materials.
- Have significant abnormal lab test results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colarodo Cancer Center | 80045 | Aurora | Colorado |
| Mayo Clinic | 32224 | Florida City | Florida |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| The University of Texas MD Anderson Cancer Center | 77030 | Texas City | Texas |
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