DSP107 plus atezolizumab versus fruquintinib for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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).
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 it's running

• University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)
  Aurora, Colorado, United States Recruiting
• University of Colorado Cancer Center - Highlands Ranch Hospital
  Highlands Ranch, Colorado, United States Recruiting
• Mayo Clinic
  Florida City, Florida, United States 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 Recruiting

Study contacts

• Study coordinator: Adam Foley Comer
• Email: adam@kahrbio.com
• Phone: +972 54 749 1753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combination treatment for metastatic colorectal cancer patients

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• Evaluating fruquintinib's safety in minority groups with advanced colorectal cancer

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• Combining fruquintinib with HAI-FOLFOX for treating refractory colorectal cancer

  This study tests whether combining a new drug called fruquintinib with a specific chemotherapy method can help people with colorectal cancer that hasn't responded to other treatments live longer and feel better.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.