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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Kahr Bio Australia Pty Ltd
Study ID
NCT07235293
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DSP107 in combination with Atezolizumab
    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.
  • Active Comparator: Fruquintinib
    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.

Primary Outcome Measure

To determine Median overall survival (mOS) in participants treated with the combination of DSP107 and atezolizumab versus fruquintinib. [ Time Frame: From Day 1 until date of death from any cause assessed up to 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)AuroraColorado80045
Hannah Robinson (PRINCIPAL_INVESTIGATOR)
University of Colorado Cancer Center - Highlands Ranch HospitalHighlands RanchColorado80129
Hannah Robinson (PRINCIPAL_INVESTIGATOR)
Mayo ClinicFlorida CityFlorida32224
Conor O'Donnell, Dr (PRINCIPAL_INVESTIGATOR)
Duke University Medical Center - Duke Cancer CenterDurhamNorth Carolina27710
Nicholas DeVito (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Anwaar Saeed, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterTexas CityTexas77030
Maria Pia Morelli, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Colorado Hospital- Anschutz Cancer Center Pavillion (ACP)· Aurora, COUniversity of Colorado Cancer Center - Highlands Ranch Hospital· Highlands Ranch, COMayo Clinic· Florida City, FLDuke University Medical Center - Duke Cancer Center· Durham, NCUPMC Hillman Cancer Center· Pittsburgh, PAThe University of Texas MD Anderson Cancer Center· Texas City, TX

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