Phase 2 N=254 Randomized Treatment

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Metastatic Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02083653 ↗

Enrolled (actual)

254

Serious AEs

25.3%

Results posted

Dec 2018

Primary outcome: Primary: Overall Survival (OS) Time — 7.9; 10.3; 9.6 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sym004 (12 mg/kg) (Drug); Sym004 (9/6 mg/kg) (Drug); Best Supportive Care (BSC) (Other); Fluorouracil (5-FU) (Drug); Capecitabine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Symphogen A/S
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS) Time	7.9; 10.3; 9.6	—
SECONDARY Best Overall Response (OR) According to the Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)	0; 0; 1; 11; 8; 1	—
SECONDARY Progression Free Survival (PFS) Time	2.8; 2.7; 2.6	—
SECONDARY Time to Treatment Failure (TTF)	2.1; 2.6; 1.6	—
SECONDARY Occurrence and Nature of Adverse Events (AEs), as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).	83; 84; 67; 27; 23; 12	—
SECONDARY Relative Dose Intensity of Sym004	80.49; 88.91	—
SECONDARY Pharmacokinetic (PK) Parameters: Sym004 Concentrations	0.50; 0.50; 0.50; 0.75; 182.95; 174.44	—
SECONDARY Pharmacokinetic (PK) Parameters: Time of Maximum Plasma Concentration (Tmax)	3.14; 2.79; 2.82; 2.33; 3.01; 2.34	—
SECONDARY Host Immune Response: Number of Subjects With Anti-drug Antibodies (ADAs) to Sym004 Over Time	78; 81; 2; 0; 1; 0	—
SECONDARY Quality of Life Assessed by the EORTC QLQ-C30 (Version 3)	55.5; 59.7; 55.8; 57.4; 59.4; 59.7	—
SECONDARY Quality of Life Assessed by EORTC QLQ-CR29	76.2; 80.1; 75.8; 76.4; 77.6; 78.2	—
SECONDARY Quality of Life Assessed by FACT-EGFRI-18 for Skin Rash	22.9; 23.1; 24.3; 18.0; 19.7; 25.1	—

Summary

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Eligibility Criteria

Inclusion Criteria

Written informed consent obtained before undergoing any study-related activities
Male or female, at least 18 years of age
Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
Measurable disease defined as one or more target lesions according to RECIST
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
Other protocol defined inclusion criteria could apply

Exclusion Criteria

Pretreatment with regorafenib.
Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
Magnesium less than 0.9 milligram per deciliter (mg/dL)
Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
Other protocol defined exclusion criteria could apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02083653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.