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

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. * LTFU for a period of up to 5 years from randomization.

• Incidence and severity of adverse events (AEs) [Срок оценки: From Screening to Follow-up (30 to 90 Days Post IP)]
• Changes in 12-lead ECG parameters [Срок оценки: From Baseline through to end of treatment visit, an average of 6 months]
• Change in Overall Survival (OS) [Срок оценки: From randomization through study participation, with survival follow up at approximately 4-month (± 1 month) intervals for up to 5 years from randomization]
• Change from Baseline in Quality of Life (QoL) [Срок оценки: From Baseline through to end of treatment visit, an average of 6 months]
• Change from Baseline in Systolic and Diastolic Blood Pressure [Срок оценки: From Baseline through to end of treatment visit, an average of 6 months]
• Change from Baseline in Pulse Rate [Срок оценки: From Baseline through to end of treatment visit, an average of 6 months]
• To evaluate the immunogenicity of DSP107 when administered in combination with atezolizumab. [Срок оценки: From Baseline through to end of treatment visit, an average of 6 months]