DSP107 plus atezolizumab versus fruquintinib for advanced colorectal cancer

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

This test will see if giving DSP107 together with atezolizumab works better and is as safe as fruquintinib for adults with advanced microsatellite-stable colorectal cancer who have already tried standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kahr Medical (Industry-sponsored)
• Drugs / interventions: atezolizumab, fruquintinib, bevacizumab
• Locations: 16 sites (Aurora, Colorado and 15 other locations)
• Trial ID: NCT07235293 on ClinicalTrials.gov

What this trial studies

This Phase 2b, randomized, open-label, multicenter study enrolls adults with advanced MSS or pMMR colorectal cancer who have progressed on or are intolerant to standard therapies. Participants are randomized 1:1 to receive DSP107 plus atezolizumab on a 28-day cycle or oral fruquintinib on days 1–21 of each 28-day cycle, with treatment continued until progression or unacceptable toxicity. The trial will measure tumor response by RECIST v1.1, safety and tolerability, and pharmacokinetics, with regular imaging and safety assessments. Enrollment occurs at several U.S. academic centers and excludes prior treatment with fruquintinib or regorafenib.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed inoperable MSS or pMMR colorectal cancer, measurable disease, and progression or intolerance after standard therapies (up to three prior lines) who have not received fruquintinib or regorafenib are the intended candidates.

Not a fit: Patients with MSI-high tumors, active autoimmune disease, unresolved grade 2+ toxicities from prior therapy, recent other malignancies, or prior fruquintinib/regorafenib exposure are unlikely to benefit or are ineligible.

Why it matters

Potential benefit: If successful, the combination could improve tumor response and extend disease control for people with MSS colorectal cancer who have limited treatment options.

How similar studies have performed: Previous efforts to make checkpoint inhibitors effective in MSS colorectal cancer have shown limited success, so this specific DSP107 plus atezolizumab approach is relatively novel with limited prior proof-of-concept.

Eligibility criteria

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.

Exclusion Criteria:

1. Central nervous system (CNS) metastases unless stable 2 months post definitive therapy with steroids.
2. Unresolved AEs of Grade 2 or higher from prior anticancer therapy.
3. Past or current history of autoimmune disease or immune deficiency.
4. History of other malignancy within 3 years of first study treatment cycle.
5. Current or recent treatment with certain therapies including specified anticancer treatments, modulators of CYP3A4 and immunomodulating therapies (prior treatment with CPIs is not exclusory).
6. Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test product.
7. Clinically significant abnormal laboratory safety tests.

Where this trial is running

Aurora, Colorado and 15 other locations

• University of Colarodo Cancer Center — Aurora, Colorado, United States (Not_yet_recruiting)
• Mayo Clinic — Florida City, Florida, United States (Not_yet_recruiting)
• Duke University Medical Center - Duke Cancer Center — Durham, North Carolina, United States (Recruiting)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
• The University of Texas MD Anderson Cancer Center — Texas City, Texas, United States (Not_yet_recruiting)
• The Queen Elizabeth Hospital — Woodville, Adelaide, Australia (Recruiting)
• Chris O'brien Lifehouse — Camperdown, New South Wales, Australia (Recruiting)
• Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
• Icon Cancer Centre — South Brisbane, Queensland, Australia (Recruiting)
• Flinders Medical Centre SA — Bedford Park, South Australia, Australia (Recruiting)
• Monash Health — Clayton, Victoria, Australia (Recruiting)
• Footscray Hospital - Western Health — Footscray, Victoria, Australia (Recruiting)
• Austin Health — Heidelberg, Victoria, Australia (Recruiting)
• Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
• Sunshine Hospital - Western Health — Saint Albans, Victoria, Australia (Recruiting)
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Adam Foley Comer

Conditions Colorectal Cancer