Sacituzumab Govitecan in Metastatic Colorectal Cancer

Progression Free Survival (PFS)

This is a Phase: II/III, open-label, multicenter (at least four centers in Germany) study of
 Sacituzumab Govitecan (SG) in metastatic colorectal cancer patients who are refractory to at
 least two lines of standard of care chemotherapy and not eligible for local therapy. There is
 no upper limit in the previous therapy lines. Patients must have documented progression or
 intolerability to combination chemotherapy including 5-fluoruacil or its prodrugs and
 derivates, Oxaliplatin and Irinotecan or a combination of the aforementioned. Previous
 biologicals/antibodies/small molecules including anti-EGFR and anti-VEGF directed therapies
 are allowed but not mandatory to meet eligibility. Trifluridin/Tipiracil (TAS102) or
 Regorafenib are allowed but not mandatory as previous therapies for PART I and PART II of the
 trial. All patients must have a documented Irinotecan-free interval of at least 6 months to
 be eligible for the study.
 
 The study consists of two parts:
 
 PART I: a single arm run in phase, treating 20 patients with Sacituzumab Govitecan (SG) PART
 II: a 1:1 randomized open label phase, comparing 30 patients treated with SG vs. 30 patients
 treated according to Physicians Choice (PhC). Crossover to the experimental arm (SG) is
 allowed in case of progression in the standard arm (PhC).
 
 PART II will only be started if significant clinical efficacy and activity is observed in
 PART I.