RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Kahr Bio Australia Pty Ltd • ClinicalTrials.gov ID: NCT07235293

Registry updated: 2026-08-20

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Description

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.

Interventions

DSP107 + Atezolizumab (Drug)
DSP107 infusion begins \~30 (±10) minutes after completion of atezolizumab infusion on Day 1.
Fruquintinib (Drug)
5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.

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.

Conditions

Colorectal Cancer

Locations

University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP) — Aurora, Colorado, United States
University of Colorado Cancer Center - Highlands Ranch Hospital — Highlands Ranch, Colorado, United States
Mayo Clinic — Florida City, Florida, United States
Duke University Medical Center - Duke Cancer Center — Durham, North Carolina, United States
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center — Texas City, Texas, United States
The Queen Elizabeth Hospital — Woodville, Adelaide, Australia
Chris O'brien Lifehouse — Camperdown, New South Wales, Australia
Port Macquarie Base Hospital (Mid North Coast Cancer Institute), Wrights Road, — Port Macquarie, New South Wales, Australia
Westmead Hospital — Westmead, New South Wales, Australia
Icon Cancer Centre — South Brisbane, Queensland, Australia
Flinders Medical Centre SA — Bedford Park, South Australia, Australia
Monash Health — Clayton, Victoria, Australia
Footscray Hospital - Western Health — Footscray, Victoria, Australia
Austin Health — Heidelberg, Victoria, Australia
Alfred Hospital — Melbourne, Victoria, Australia
Sunshine Hospital - Western Health — Saint Albans, Victoria, Australia
Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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