Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients
- Registration Number
- NCT02568046
- Lead Sponsor
- Symphogen A/S
- Brief Summary
This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W).
- Detailed Description
In the Phase 1b (Dose-Escalation) portion of the trial, patients will be sequentially enrolled to dose-escalation cohorts until establishment of the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of Sym004 in combination with FOLFIRI.
The Phase 2a (Dose-Expansion) portion of the trial is expected to begin after establishing the RP2D.
Note: In January 2017, the trial was terminated during Phase 1b and enrollment was prematurely discontinued. The primary objective changed to assess the safety of the treatment combination; collection of data for secondary and exploratory objectives was omitted.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sym004 12 mg/kg + FOLFIRI Sym004 Phase 1b, Dose-Escalation: Dose Level 1 Sym004 12 mg/kg + FOLFIRI FOLFIRI Phase 1b, Dose-Escalation: Dose Level 1 Sym004 9 mg/kg + FOLFIRI Sym004 Phase 1b, Dose-Escalation: Dose Level -1 Sym004 9 mg/kg + FOLFIRI FOLFIRI Phase 1b, Dose-Escalation: Dose Level -1 Sym004 (RP2D) + FOLFIRI Sym004 Phase 2a, Dose-Expansion: Sym004 in the RP2D in combination with FOLFIRI Sym004 (RP2D) + FOLFIRI FOLFIRI Phase 2a, Dose-Expansion: Sym004 in the RP2D in combination with FOLFIRI
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03). 15 months AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (e.g., treatment-emergent AE \[TEAE\]) were summarized according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred after the first treatment administration.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Sharp Memorial Hosptal
🇺🇸San Diego, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
University Cancer & Blood Center, LLC
🇺🇸Athens, Georgia, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Madrid Sanchinarro
🇪🇸Madrid, Spain
UCLA School of Medicine🇺🇸Los Angeles, California, United States