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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07235293.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Name Not Available
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.
Lead OrganizationKahr Bio Australia Pty Ltd
