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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 · Kahr Medical
In plain English
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Official title
A Randomized, Open-label, Phase 2b Study to Compare the Efficacy of DSP107 in Combination With Atezolizumab Versus Fruquintinib in Patients With Advanced Microsatellite Stable Colorectal Cancer
About this study
This Phase 2b, randomized, open-label, multicenter study will enroll participants with advanced MSS or mismatch repair-proficient (pMMR) colorectal cancer who have progressed on, or shown intolerance to, standard therapies, including fluoropyrimidine, irinotecan, oxaliplatin, trifluridine/tipiracil (Lonsurf), bevacizumab, and epidermal growth factor receptor (EGFR) inhibitors if RAS wild-type. Participants with BRAF V600E mutation, HER2 amplification/overexpression, KRAS G12C mutation, RET fusion, or NTRK fusion may also have received one prior targeted therapy. Prior treatment with fruquintinib or regorafenib is not allowed.
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.
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).
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:
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.
Study design
Enrollment target: 90 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-16
Estimated completion: 2027-04-30
Last updated: 2026-04-09
Interventions
Drug: DSP107 + AtezolizumabDrug: Fruquintinib
Primary outcomes
- • To determine Median overall survival (mOS) in participants treated with the combination of DSP107 and atezolizumab versus fruquintinib. (From Day 1 until date of death from any cause assessed up to 2 years)
Sponsor
Kahr Bio Australia Pty Ltd · industry
With: Novotech (Australia) Pty Limited
Contacts & investigators
ContactAdam Foley Comer · contact · adam@kahrbio.com · +972 54 749 1753
All locations (16)
University of Colarodo Cancer CenterNot Yet Recruiting
Aurora, Colorado, United States
Mayo ClinicNot Yet Recruiting
Florida City, Florida, United States
Duke University Medical Center - Duke Cancer CenterRecruiting
Durham, North Carolina, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer CenterNot Yet Recruiting
Texas City, Texas, United States
The Queen Elizabeth HospitalRecruiting
Woodville, Adelaide, Australia
Chris O'brien LifehouseRecruiting
Camperdown, New South Wales, Australia
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Icon Cancer CentreRecruiting
South Brisbane, Queensland, Australia
Flinders Medical Centre SARecruiting
Bedford Park, South Australia, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Footscray Hospital - Western HealthRecruiting
Footscray, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Sunshine Hospital - Western HealthRecruiting
Saint Albans, Victoria, Australia
Sir Charles Gairdner HospitalRecruiting
Nedlands, Western Australia, Australia