Sacituzumab Govitecan in Metastatic Colorectal Cancer

Sponsor
University Hospital Heidelberg
Study ID
NCT06243393
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Govitecan (SG) — DRUG
    Treatment with Sacituzumab Govitecan (SG)
  • Physicians Choice (PhC). — DRUG
    Treatment according to oncologic guidelines.

Study Details

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.

Key Dates

First listed
Feb 6, 2024
Start date
Apr 19, 2024
Status verified
Jul 2024
Primary completion
Aug 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sacituzumab Govitecan (SG)
    Treatment with Sacituzumab Govitecan (SG) .
  • Active Comparator: Physicians Choice (PhC).
    Treatment according to oncologic guidelines.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: time from randomization into the study to time of progression of the disease or death from any cause, whatever occurs first, assessed on average up to 1 year ]

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