Clinical trial · Interventional
Sym004 in Patients With Advanced Solid Tumors
An Open-label, Multi-center Phase I Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Sym004 in Patients With Advanced Solid Tumors
NCT01117428CI-TRIAL-00035288completedPhase 1 / Phase 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 trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sym004 | Drug | Futuximab/Modotuximab Mixture | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sym004
- interventionNames
- Drug: Sym004
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- Visit 2 until first follow-up visit (up to 66 weeks)
- description
- The AEs were used as a primary endpoint. AEs were summarized using descriptive statistics and presented overall by system organ class and preferred term. The frequencies of AEs were presented including number and percentages of participants with events and the total number of events.
Secondary outcomes (3)
- measure
- Antitumor Activity
- timeFrame
- Up to 62 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Part A: 1\. Patients with refractory or recurrent advanced late stage solid tumors without available therapeutic options . Part B, C, D, E and F: 1. Patients with refractory or recurrent advanced mCRC and wild-type KRAS who have progressed on epidermal growth factor receptor (EGFR) Ab treatment. 2. Patients wit confirmed response while on treatment anti-EGFR Ab treatment. 3. Documented disease progression during or within 6 months after cessation of anti-EGFR Ab treatment. 4. Patients must be willing to have a biopsy performed from a tumor lesion at screening and at Visit 6. Part A, B, C, D, E and F: 1. Histologically or cytologically confirmed diagnosis of cancer 2. Failure and/or intolerance to standard chemotherapy 3. Life expectancy of at least 3 months 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Exclusion Criteria: 1. Patients with clinically symptomatic brain metastases. 2. Received the following treatments prior to Visit 2: * Cytotoxic or cytostatic anti-cancer chemotherapy within 4 weeks * Total resection or irradiation of the target lesion * Antibody therapy within 4 weeks and vaccines within 12 weeks * Tyrosin kinase inhibitors within 4 weeks * Any investigational agent within 4 weeks 3. Diarrhea CTCAE \>1 4. Skin rash CTCAE \>1 5. Abnormal organ or bone marrow function. 6. Use of immunosuppressive agents for the past 4 weeks prior to trial start, including systemic corticosteroids used at doses above 20mg/day of prednisolone or equivalent. 7. History of other malignancy within 5 years prior to trial start, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix (not in Part A). 8. Active severe infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the investigator. 9. Known HIV positive 10. Known active hepatitis B or C 11. Patients with known uncontrolled allergic conditions or allergy to the study drug and/or their components. 12. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities and controlled and well treated chronic atrial fibrillation. 13. Significant concurrent, uncontrolled medical condition evaluated by the investigator to interfere with effect of the trial drug.
References
Publications (1)
- DERIVEDDienstmann R, Patnaik A, Garcia-Carbonero R, Cervantes A, Benavent M, Rosello S, Tops BB, van der Post RS, Argiles G, Skartved NJ, Hansen UH, Hald R, Pedersen MW, Kragh M, Horak ID, Braun S, Van Cutsem E, Tolcher AW, Tabernero J. Safety and Activity of the First-in-Class Sym004 Anti-EGFR Antibody Mixture in Patients with Refractory Colorectal Cancer. Cancer Discov. 2015 Jun;5(6):598-609. doi: 10.1158/2159-8290.CD-14-1432. Epub 2015 May 11. PMID 25962717