Sacituzumab Govitecan in Metastatic Colorectal Cancer

Phase 2

Recruiting

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Physicians Choice (PhC).; Drug: Sacituzumab Govitecan (SG)

• Registration Number: NCT06243393
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-06
• Study Start: 2024-04-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10
• Primary Completion: 2028-08-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physicians Choice (PhC).	Physicians Choice (PhC).	Treatment according to oncologic guidelines.
Sacituzumab Govitecan (SG)	Sacituzumab Govitecan (SG)	Treatment with Sacituzumab Govitecan (SG) .

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	time from randomization into the study to time of death or end of study (EOS), assessed on average up to 1 year	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.

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, BW, Germany