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Sacituzumab govitecan

Immunoconjugates

Immunologic Factors

Treatment with Sacituzumab Govitecan (SG) .

Treatment according to oncologic guidelines.

Treatment with Sacituzumab Govitecan (SG)

Sacituzumab Govitecan (SG)

Physicians Choice (PhC).

Bruno Köhler, Dr.

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.

Sacituzumab Govitecan in Metastatic Colorectal Cancer

A Randomized, Open Label, Multicenter Phase II/III Trial of Sacituzumab Govitecan Compared to Standard of Care in Metastatic, Refractory Colorectal Cancer Patients

Progression Free Survival (PFS): as the time from randomization into the study to time of progression of the disease or death from any cause, whatever occurs first. Patients without an applicable event are censored on the last date of follow-up.

Overall Survival (OS): as time from randomization until death or end of study (EOS). Patients without an applicable event are censored on the last date of follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sacituzumab Govitecan in Metastatic Colorectal Cancer	NCT06243393	Metastatic Colo...	Sacituzumab Gov... Physicians Choi...	18 Years -	University Hospital Heidelberg
Sacituzumab Govitecan in Metastatic Colorectal Cancer	NCT06243393	Metastatic Colo...	Sacituzumab Gov... Physicians Choi...	18 Years -	University Hospital Heidelberg

Spots Global Cancer Trial Database for physicians choice (phc).