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
Kahr Bio Australia Pty Ltd
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.
Description
This Phase 2b, randomized, open-label, multicenter study will enroll participants with advanced MSS or mismatch repair-proficient (pMMR) colorectal cancer who have progressed on, or shown intolerance to, standard therapies, including fluoropyrimidine, irinotecan, oxaliplatin, trifluridine/tipiracil (Lonsurf), bevacizumab, and epidermal growth factor receptor (EGFR) inhibitors if RAS wild-type. Participants with BRAF V600E mutation, HER2 amplification/overexpression, KRAS G12C mutation, RET fusion, or NTRK fusion may also have received one prior targeted therapy. Prior treatment with fruquintin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Are ≥ 18 years of age with a life expectancy of \> 3 months. 2. 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. 3. Measurable disease per RECIST v1.1…
Interventions
- DrugDSP107 + Atezolizumab
DSP107 infusion begins \~30 (±10) minutes after completion of atezolizumab infusion on Day 1.
- DrugFruquintinib
5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.
Locations (16)
- University of Colarodo Cancer CenterAurora, Colorado
- Mayo ClinicFlorida City, Florida
- Duke University Medical Center - Duke Cancer CenterDurham, North Carolina
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
- The University of Texas MD Anderson Cancer CenterTexas City, Texas
- The Queen Elizabeth HospitalWoodville, Adelaide