Clinical trial · Interventional
Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer
Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies
NCT02083653CI-TRIAL-00038135completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care (BSC) | Other | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Fluorouracil (5-FU) | Drug | Fluorouracil | ALIAS |
| Sym004 (12 mg/kg) | Drug | Futuximab/Modotuximab Mixture | ALIAS |
| Sym004 (9/6 mg/kg) | Drug | Futuximab/Modotuximab Mixture | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: Sym004 (12 mg/kg)
- description
- Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal.
- interventionNames
- Drug: Sym004 (12 mg/kg)
- type
- EXPERIMENTAL
- label
- Arm B: Sym004 (9/6 mg/kg)
- description
- Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal.
- interventionNames
- Drug: Sym004 (9/6 mg/kg)
- type
- ACTIVE_COMPARATOR
- label
- Arm C: Investigator's Choice
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDFayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.