A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorectal Cancer.
NCT ID: NCT07235293
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2026-01-20
2027-04-30
Brief Summary
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Detailed Description
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Participants will be randomized 1:1 into two arms:
Group A (Experimental): DSP107 10 mg/kg intravenously on Days 1, 8, and 15 of each 28-day cycle, administered after atezolizumab 1680 mg IV on Day 1 of each cycle. DSP107 infusion may be shortened after initial tolerance. Atezolizumab infusion may be shortened from 60 to 30 minutes if well tolerated.
Group B (Active Comparator): Fruquintinib 5 mg orally once daily on Days 1-21 of each 28-day cycle, with dosing diaries maintained by participants.
Total duration of study participation for each participant will vary based on factors including treatment tolerability, disease progression and other study discontinuation criteria.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
DSP107 + Atezolizumab
DSP107 infusion begins \~30 (±10) minutes after completion of atezolizumab infusion on Day 1.
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.
Fruquintinib
5 mg orally, once daily (with or without food), on Days 1-21 of each 28-day cycle, followed by 7 days off.
Interventions
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DSP107 + Atezolizumab
DSP107 infusion begins \~30 (±10) minutes after completion of atezolizumab infusion on Day 1.
Fruquintinib
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
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Inclusion Criteria
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).
Note: Lines of therapy are defined by disease progression between therapies. Participants who discontinue their prior regimen due to toxicity (in the absence of disease recurrence/progression) will also have their prior therapy count as one prior regimen.
3. Measurable disease per RECIST v1.1.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Novotech (Australia) Pty Limited
INDUSTRY
Kahr Bio Australia Pty Ltd
INDUSTRY
Responsible Party
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Locations
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University of Colarodo Cancer Center
Aurora, Colorado, United States
Mayo Clinic
Florida City, Florida, United States
Duke Cancer Institute - 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
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 Health
Melbourne, Victoria, Australia
Sunshine Hospital - Western Health
Saint Albans, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Other Identifiers
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DSP107_003
Identifier Type: -
Identifier Source: org_study_id