Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer.

• Status: Withdrawn
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of the experimental drug abituzumab (EMD525797) in combination with cetuximab and FOLFIRI in RAS wild-type, left-sided, metastatic colorectal cancer patients with high ανβ6 integrin expression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SFJ Pharmaceuticals X, LTD.
• Collaborators: Academic and Community Cancer Research United; AIO-Studien-gGmbH; Merck KGaA; Merck KGaA, Darmstadt, Germany; SFJ Pharmaceuticals, Inc.
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

1. Signed and dated written informed consent prior to any study specific procedure;

2. Age: ≥18 years;

3. Evidence of newly diagnosed stage IV metastatic colorectal cancer. Primary tumor location on the left side of the Colon (including left splenic flexure) or rectum;

4. Demonstrated wild-type RAS mutation status in the tumor (primary tumor or metastasis) by local assessment;

5. Tumor tissue specimen shows high ανβ6 integrin expression, as determined by central laboratory assessment;

6. Tumor tissue specimen (formalin-fixed, paraffin-embedded block) preferably from primary resection and/or if available from a surgical sample from metastatic site must be available for central laboratory based ανβ6 integrin expression analysis. (No Fine Needle Aspiration [FNA] will be accepted);

7. At least 1 radiographically documented measurable lesion in a previously non-irradiated area according to RECIST (Version 1.1), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as ≥2 cm by conventional techniques or ≥1 cm by spiral CT scan;

8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;

9. Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study;

Exclusion Criteria:

1. Demonstrated any RAS or BRAF mutation;

2. Prior anti-EGFR or other targeted therapy;

3. Prior chemotherapy of the colorectal cancer, except for (neo) adjuvant therapy completed at least 6 months before randomization;

4. Radiotherapy (localized radiotherapy for pain relief is allowed to non-target lesions);

5. Investigational drug treatment for the treatment of malignancies in the past;

6. Concurrent participation in another interventional clinical study;

7. Pregnancy (exclusion confirmed with beta-hCG test) or lactation;

8. Any history or evidence of brain metastases or leptomeningeal metastases;

9. History of secondary malignancy within the past 5 years, except for basal cell carcinoma or carcinoma in situ of the cervix uteri, if treated with curative intent;

10. Concomitant chronic systemic immune or hormone therapy not indicated in this study protocol (except for physiologic replacement; steroids up to 10 mg per day of prednisone equivalent or topical and inhaled steroids are allowed);

11. Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), or clinically relevant cardiomyopathy;

12. Uncontrolled hypertension defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg under resting conditions;

13. History of myocardial infarction in the last 12 months, or a high risk of uncontrolled arrhythmia, coagulation disorder associated with bleeding or recurrent thrombotic events, with the exception of arterial fibrillation treated with anti-coagulants;

14. Recent peptic ulcer disease (endoscopically proven) within 6 months of randomization, chronic inflammatory bowel disease, or acute/chronic ileus;

15. Active infection (requiring IV antibiotics and/or antiviral therapy), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection, AIDS;

16. Presence of any contra-indications or known hypersensitivity to treatment with abituzumab, cetuximab, and FOLFIRI, or to any of the excipients of these drugs;

17. Concomitant treatment with prohibited medications;

18. Medical or psychological conditions that would not permit the patient to complete the study.