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

NCT07235293

RecruitingPhase 2

Sponsor: Kahr Bio Australia Pty Ltd

Conditions: Colorectal Cancer

Interventions: DSP107 + Atezolizumab, Fruquintinib

Countries: United States, Australia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (18)

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
Port Macquarie, 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