EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer

1. Male or female patients aged ≥ 18 and < 75 years. 2. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor located from the splenic flexure to the rectum), with measurable disease per RECIST v1.1.

Patients who received any approved or investigational anti-cancer therapy must have discontinued such therapy at least 4 weeks prior to the first dose of study treatment or 5 half-lives of the agent, whichever is shorter.

Patients who received local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines must have discontinued such therapy at least 2 weeks prior to the first dose of study treatment. No therapeutic radiopharmaceuticals within 8 weeks prior to the first dose of EMB-01.

Arm A (irinotecan) and Arm B (TAS-102): Prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, plus prior anti-VEGF therapy (with or without anti-EGFR therapy), with disease progression or intolerance; no prior TAS-102/fruquintinib/regorafenib. If prior anti-EGFR therapy was received, the patient must have achieved CR, PR, or SD, with the last anti-EGFR dose administered at least 4 months prior to the first study drug dose.