Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

Phase 1

Terminated

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Sym004; Drug: FOLFIRI

• 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.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-05
• Study Start: 2016-03-15
• Primary Completion: 2017-05-15
• Study Completion: 2018-05-05
• Results First Submitted: 2018-12-19
• Results First Submitted QC: 2018-12-19
• Results First Posted: 2019-01-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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.

Trial Locations

Locations (8)

Sharp Memorial Hosptal; 🇺🇸 San Diego, California, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Madrid Sanchinarro; 🇪🇸 Madrid, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

University Cancer & Blood Center, LLC; 🇺🇸 Athens, Georgia, United States

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States