OncoMatch/Clinical Trials/NCT06243393
Sacituzumab Govitecan in Metastatic Colorectal Cancer
Is NCT06243393 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Sacituzumab Govitecan (SG) and Physicians Choice (PhC). for metastatic colorectal cancer.
Treatment: Sacituzumab Govitecan (SG) · Physicians Choice (PhC). — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Excluded: MSH2 deficient
Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer
Excluded: MSH6 deficient
Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer
Excluded: MLH1 deficient
Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer
Excluded: PMS2 deficient
Known microsatellite instable (MSI-H) / MMR-protein deficient (dMMR) colorectal cancer
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: fluoropyrimidine
must include fluoropyrimidine
Must have received: oxaliplatin
must include oxaliplatin
Must have received: irinotecan
must include irinotecan
Cannot have received: irinotecan
Exception: allowed if >6 months since last dose and responsive to induction therapy
No Irinotecan treatment within the last 6 months. Patients that received Irinotecan treatment more than 6 months prior to inclusion, must have been responsive to Irinotecan induction therapy
Cannot have received: anticancer biologic agent
Exception: allowed if >2 weeks prior to enrollment
Have had a prior anticancer biologic agent within 2 weeks prior to enrollment
Cannot have received: chemotherapy
Exception: allowed if >2 weeks prior to enrollment and recovered from AEs
have had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to enrollment AND have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry
Cannot have received: targeted therapy
Exception: allowed if >2 weeks prior to enrollment and recovered from AEs
have had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to enrollment AND have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry
Cannot have received: radiation therapy
Exception: allowed if >2 weeks prior to enrollment and recovered from AEs
have had prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to enrollment AND have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry
Lab requirements
Blood counts
Hemoglobin <9 g/dl; Neutrophil count <1500/l; Platelet count <100000/l
Kidney function
Estimated creatinine clearance <30 ml/min (Cockcroft and Gault formula)
Liver function
Total bilirubin >1.5x ULN (except Gilbert Syndrome, then >3.0 mg/dl); AST/ALT >2.5x ULN (or >5.0x ULN with liver metastases); serum albumin <3 g/dl
Inadequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment (growth factor support is not allowed within 14 days prior to baseline labs; Hemoglobin <9 g/dl, Neutrophil count <1500/l, Platelet count <100000/l, Total bilirubin >1.5 times the institutional upper limit of normal (ULN, except patients with Gilbert Syndrome, there >3.0 mg/dl), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 ULN; subjects with documented liver metastases may have an AST and ALT of >5.0 ULN and serum albumin <3 g/dl, Estimated creatinine clearance calculated creatinine clearance <30 ml/minute according to the Cockcroft and Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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