Clinical trial · Interventional
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
An Open-label, Randomized, Controlled, Multicenter, Phase I/II Trial Investigating 2 EMD 525797 Doses in Combination With Cetuximab and Irinotecan Versus Cetuximab and Irinotecan Alone, as Second-line Treatment for Subjects With K-ras Wild Type Metastatic Colorectal Cancer (mCRC)
- 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)
The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| EMD 525797 1000 mg | Drug | — | UNRESOLVED |
| EMD 525797 250 mg | Drug | — | UNRESOLVED |
| EMD 525797 500 mg | Drug | — | UNRESOLVED |
| EMD 525797 750 mg | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Safety part: EMD 525797 250 mg + Standard of Care (SoC)
- description
- EMD 525797 250 mg in combination with cetuximab and irinotecan
- interventionNames
- Drug: EMD 525797 250 mg
- Drug: Cetuximab
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Safety part: EMD 525797 500 mg + SoC
- description
- EMD 525797 500 mg in combination with cetuximab and irinotecan
- interventionNames
- Drug: EMD 525797 500 mg
- Drug: Cetuximab
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis * Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease * Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (PD) (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing retreatment * At least 1 radiographically documented measurable lesion in a previously non irradiated area according to Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as greater than or equal to (\>=) 2 centimeter (cm) by conventional techniques or \>=1 cm by spiral computed tomography (CT) scan * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or Karnofsky performance status (KPS) \>= 80 percent (%) * Absolute Neutrophil Count (ANC) \>=1.5 x 10\^9/Liter * Platelets \>=100 x 10\^9/Liter * Hemoglobin \>=9 gram per deciliter (g/dL) (without transfusions) * Bilirubin less than or equal to (\<=) 1.5 x upper limit normal (ULN) * Aspartate transaminase (AST) \<=5 x ULN and alanine transaminase (ALT) \<=5 x ULN * Serum creatinine \<=1.25 x ULN and/or creatinine clearance \>=50 milliliter per minute (mL/min) * International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits * Sodium and potassium within normal limits or \<=10% above or below (supplementation permitted) Exclusion Criteria: * Previous treatment with any inhibitor of Epidermal Growth Factor Receptor (EGFR) * Known brain metastasis and/or leptomeningeal disease * Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry; planned major surgery during the trial * Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed) * Clinically relevant coronary artery disease (New York Heart Association \[NYHA\] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia * Uncontrolled hypertension defined as systolic blood pressure \>=160 millimeter of mercury (mmHg) and/or diastolic blood pressure \>=100 mmHg under resting conditions * History of coagulation disorder associated with bleeding or recurrent thrombotic events * History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of trial treatment start * Chronic inflammatory bowel disease, or acute/chronic ileus * Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection
References
Publications (1)
- DERIVEDElez E, Kocakova I, Hohler T, Martens UM, Bokemeyer C, Van Cutsem E, Melichar B, Smakal M, Csoszi T, Topuzov E, Orlova R, Tjulandin S, Rivera F, Straub J, Bruns R, Quaratino S, Tabernero J. Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial. Ann Oncol. 2015 Jan;26(1):132-140. doi: 10.1093/annonc/mdu474. Epub 2014 Oct 15. PMID 25319061