Clinical trial · Interventional
Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
- 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 clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-011 | Drug | — | UNRESOLVED |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CT-011 in combination with FOLFOX
- description
- CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
- interventionNames
- Drug: CT-011
- Drug: FOLFOX
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX
- description
- FOLFOX (FOLFOX-4 or mFOLFOX6) administered every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation.
- interventionNames
- Drug: FOLFOX
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient's age is 18 years or older, both genders. 2. Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted. 3. ECOG performance status ≤ 1 4. At least 4 weeks from prior major surgery or radiotherapy. 5. Life expectancy \>3 months 6. Hematology: ANC ≥ 1.5X109/L; Platelets \>100x109/L. 7. Adequate Renal function 8. Adequate Hepatic functions 9. Normal Cardiac function Exclusion Criteria: 1. Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months. 2. Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease. 3. Patients on concurrent anti cancer therapy other than that allowed in the study. 4. Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids 5. Presence of clinically apparent or suspected brain metastasis. 6. Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months. 7. Serious active infection at the time of pre-study screening. 8. Active or history of autoimmune disorders/conditions. 9. Women who are pregnant or lactating 10. Concurrent active malignancy. 11. Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease. 12. Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years. 13. Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study. 14. Patients with history of life threatening allergic reactions to food or drugs 15. Patients with symptomatic peripheral neuropathy\> Grade 1. 16. Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.
References
Publications (0)
Data not yet available