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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 28 days, 90 days, 5 years
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "DSP107 infusion may be shortened after initial tolerance."
  • "Atezolizumab infusion may be shortened from 60 to 30 minutes if well tolerated."
  • "Study duration for participants will include at least: * Screening Period of up to 28 days * Treatment Period of up to 24 cycles of 28 days * Safety Follow-up Period of up to 90 days\* from the last dose of IP or active comparator. * LTFU for a period of up to 5 years from randomization."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares DSP107 plus atezolizumab with fruquintinib for advanced colorectal cancer (cancer of the colon or rectum) that is microsatellite stable (MSS). It tests how well the medicines work and how safe they are. People are placed in one of the two treatment groups by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older and expected to live more than 3 months.
  • Have colorectal cancer confirmed by a tissue test that cannot be removed by surgery.
  • Have MSS and/or pMMR cancer, meaning the cancer has certain working DNA repair features.
  • The cancer got worse after certain treatments, or you could not tolerate those treatments.
  • Have had no more than 3 courses of different cancer treatments.
  • Have cancer that can be measured using the study’s rules.

Who can't join

  • Cancer has spread to the brain or spinal cord, unless stable for 2 months after treatment with steroids, as specified by the study.
  • Still have moderate or worse side effects from past cancer treatment.
  • Have or have had a disease where the immune system attacks the body, or an immune system deficiency.
  • Have had another cancer within 3 years before the first study treatment.
  • Currently or recently used certain cancer drugs, medicines that affect a liver enzyme called CYP3A4, or medicines that change immune activity. Past checkpoint inhibitor treatment, a type of immune therapy, does not by itself rule you out.
  • Have a known allergy to study medicines or materials, or another medical reason you cannot receive a study medicine.
  • Have abnormal lab test results that raise important safety concerns.

Simplified for readability. The official criteria below are what the study team uses.

Official 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). 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.

Study sites (6)

CO

  • University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP) · Aurora, CO 80045Hannah Robinson · Principal investigatorMore trials in Aurora
  • University of Colorado Cancer Center - Highlands Ranch Hospital · Highlands Ranch, CO 80129Hannah Robinson · Principal investigatorMore trials in Highlands Ranch

FL

NC

  • Duke University Medical Center - Duke Cancer Center · Durham, NC 27710Nicholas DeVito · Principal investigatorMore trials in Durham

PA

TX

  • The University of Texas MD Anderson Cancer Center · Texas City, TX 77030Maria Pia Morelli, MD · Principal investigatorMore trials in Texas City