Clinical trial · Interventional
A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DSP107 + Atezolizumab | Drug | — | UNRESOLVED |
| Fruquintinib | Drug | Fruquintinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DSP107 in combination with Atezolizumab
- description
- DSP107 10 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle. Atezolizumab 1680 mg IV on Day 1 of each 28-day cycle.
- interventionNames
- Drug: DSP107 + Atezolizumab
- type
- ACTIVE_COMPARATOR
- label
- Fruquintinib
- description
- Participants will receive fruquintinib orally in 28-day cycles, for up to 24 cycles (96 weeks), or until disease progression, unacceptable toxicity, or study withdrawal.
- interventionNames
- Drug: Fruquintinib
Primary outcomes (1)
- measure
- To determine Median overall survival (mOS) in participants treated with the combination of DSP107 and atezolizumab versus fruquintinib.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available