18 and older, any sex, with Metastatic Colorectal Cancer or Colorectal Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.Primary· 4 months
Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 5) (CTCAE v5). AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology and the severity of the toxicities will be graded according to the CTCAE v5, where applicable.
At least one AE
Group
Value
95% CI
Arm A (Sym004)
2
Arm B (Futuximab)
1
At least one SAE
Group
Value
95% CI
Arm A (Sym004)
1
Arm B (Futuximab)
0
At least one AE related to Sym004
Group
Value
95% CI
Arm A (Sym004)
2
Arm B (Futuximab)
0
At least one AE related to futuximab
Group
Value
95% CI
Arm A (Sym004)
0
Arm B (Futuximab)
0
At least one SAE related to Sym004
Group
Value
95% CI
Arm A (Sym004)
0
Arm B (Futuximab)
0
At least one SAE related to futuximab
Group
Value
95% CI
Arm A (Sym004)
0
Arm B (Futuximab)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2, randomized, open-label, 3-arm trial in the ratio of 1:1:1 to either Sym004 (Arm A) versus each of its component monoclonal antibodies (mAbs), futuximab (Arm B) or modotuximab (Arm C), in genomically-selected patients with chemotherapy-refractory metastatic colorectal carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (anti-EGFR) mAb therapy. The study is designed to evaluate the relative antitumor activity of each agent as assessed by imaging studies performed after 8 weeks of treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02568046 — Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients
· Phase 1, PHASE2
· terminated
NCT01955473 — Japanese Phase 1 Trial of Sym004 in Solid Tumors
· Phase 1
· completed
Other recruiting trials for Metastatic Colorectal Cancer
Currently open trials in the same condition.
NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
· Phase 1
· recruiting
NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients
· Phase 2
· recruiting
NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma
· Phase 2
· recruiting
NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect
· Phase 2
· recruiting
NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
· recruiting
Other Symphogen A/S trials
Trials by the same sponsor.
NCT04672434 — Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
· Phase 1
· completed
NCT04641871 — Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected
· Phase 1
· completed
NCT03489343 — Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
· Phase 1
· completed
NCT03489369 — Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
· Phase 1
· completed
NCT03311412 — Sym021 Monotherapy, in Combination With Sym022 or Sym023, and in Combination With Both Sym022 and Sym023 in Patients Wit
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Symphogen A/S
Last refreshed: 28 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03549338.