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Monoclonal Antibodies

Sym004 for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Led By Josep Tabernero, MD, PhD
Research Sponsored by Symphogen A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 until first follow-up visit (up to 66 weeks)
Awards & highlights

Study Summary

This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 62 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 62 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events (AEs)
Secondary outcome measures
Antitumor Activity
Antitumor Activity Endpoints - Time-to-event Endpoints
Terminal Half-Life (T½)

Side effects data

From 2015 Phase 1 & 2 trial • 111 Patients • NCT01117428
77%
Rash
54%
Diarrhea
54%
Asthenia
46%
Hypomagnesemia
46%
Neoplasm malignant
38%
Decreased appetite
38%
Pruritus
38%
Dry skin
31%
Skin fissures
31%
Mucosal inflammation
31%
Vomiting
23%
Hypokalemia
23%
Dyspnea
23%
Erythema
23%
Edema peripheral
23%
Nausea
15%
Paronychia
15%
Conjunctivitis
15%
Constipation
15%
Blepharitis
15%
Xerosis
8%
Cough
8%
Depression
8%
Tumor pain
8%
Gastroenteritis
8%
Productive cough
8%
Urinary tract infection
8%
Onycholysis
8%
Palmar-plantar erythrodysaesthesia syndrome
8%
Skin exfoliation
8%
Hyperkalemia
8%
Fungal infection
8%
Muscle spasms
8%
Groin pain
8%
Hyperbilirubinemia
8%
Hypocalcemia
8%
Hyperglycemia
8%
Bone pain
8%
Wheezing
8%
Procedural pain
8%
Intestinal obstruction
8%
Subileus
8%
Peritonitis
8%
Sepsis
8%
Fracture
8%
Dermatosis
8%
Acne
8%
Eczema
8%
Skin hyperpigmentation
8%
Edema
8%
Fatigue
8%
Dyspepsia
8%
Stomatitis
8%
Ascites
8%
Superinfection
8%
Skin infection
8%
Blood magnesium decreased
8%
Body temperature decreased
8%
Musculoskeletal pain
8%
Back pain
8%
Arthralgia
8%
Musculoskeletal stiffness
8%
Toxicity to various agents
8%
Headache
8%
Esophageal candidiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part C: Dose Expansion Cohort
Part A: Dose Escalation
Part B: Dose Expansion Cohort
Part D: Dose Expansion Cohort
Part E: Dose Expansion Cohort
Part F: Dose Expansion Cohort

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sym004Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Futuximab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Symphogen A/SLead Sponsor
16 Previous Clinical Trials
739 Total Patients Enrolled
Josep Tabernero, MD, PhDPrincipal InvestigatorVall d´Hebron University Hospital
3 Previous Clinical Trials
264 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sym004 in Patients With Advanced Solid Tumors
2010. "Sym004 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01117428.
~7 spots leftby May 2025
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