Recruiting PHASE2 Colorectal Cancer

New treatment option for Colorectal Cancer

Official title A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.

ClinicalTrials.gov ID: NCT07235293

What this study is testing

What is DSP107 + Atezolizumab?

DSP107 + Atezolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for colorectal cancer.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Are ≥ 18 years of age with a life expectancy of \> 3 months.
  • Participants with histologically confirmed, inoperable, MSS and/or pMMR CRC which has progressed to, or is intolerant to, specified therapies (and...
  • Measurable disease per RECIST v1.1.

You likely can't join if

  • Central nervous system (CNS) metastases unless stable 2 months post definitive therapy with steroids.
  • Unresolved AEs of Grade 2 or higher from prior anticancer therapy.
  • Past or current history of autoimmune disease or immune deficiency.
  • History of other malignancy within 3 years of first study treatment cycle.
  • Current or recent treatment with certain therapies including specified anticancer treatments, modulators of CYP3A4 and immunomodulating therapies...
  • Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test product.
See the full eligibility criteria
Who can join
  • Are ≥ 18 years of age with a life expectancy of \> 3 months.
  • 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).
  • Measurable disease per RECIST v1.1.
What rules you out
  • Central nervous system (CNS) metastases unless stable 2 months post definitive therapy with steroids.
  • Unresolved AEs of Grade 2 or higher from prior anticancer therapy.
  • Past or current history of autoimmune disease or immune deficiency.
  • History of other malignancy within 3 years of first study treatment cycle.
  • Current or recent treatment with certain therapies including specified anticancer treatments, modulators of CYP3A4 and immunomodulating therapies (prior treatment with CPIs is not exclusory).
  • Known allergy or hypersensitivity to any of the test compounds, materials, or contraindication to test product.
  • Clinically significant abnormal laboratory safety tests.

The study team makes the final eligibility decision.

Where it's taking place

  • Aurora, Colorado, United States
  • Highlands Ranch, Colorado, United States
  • Florida City, Florida, United States
  • Durham, North Carolina, United States
  • Pittsburgh, Pennsylvania, United States
  • Texas City, Texas, United States
  • Woodville, Adelaide, Australia
  • Camperdown, New South Wales, Australia
  • Westmead, New South Wales, Australia
  • South Brisbane, Queensland, Australia
  • Bedford Park, South Australia, Australia
  • Clayton, Victoria, Australia
  • Footscray, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Saint Albans, Victoria, Australia
  • Nedlands, Western Australia, Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aurora, Colorado, United States; Highlands Ranch, Colorado, United States; Florida City, Florida, United States; Durham, North Carolina, United States; Pittsburgh, Pennsylvania, United States; Texas City, Texas, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.