Clinical trial · Interventional
Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer
Phase I/Ib Study of Surgical Resection or Radiofrequency Ablation (RFA) of Metastatic Lesions in the Liver in Combination With Monoclonal Antibody to OX40 (MEDI6469) in Patients With Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug expired and access to additional supply ended. PI left the institution shortly afterwards and the study will not be re-activated. Only 4 patients were enrolled.
Summary
Brief summary (as posted)
This study will test the ability of an immune modulator, anti-OX40 (MEDI6469) to alter the immune cell environment within colorectal cancer metastases. The drug will be administered to patients before surgical treatment.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI6469 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 21 Days
- description
- MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 21 days prior to surgery
- interventionNames
- Drug: MEDI6469
- type
- EXPERIMENTAL
- label
- 14 Days
- description
- MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 14 days prior to surgery
- interventionNames
- Drug: MEDI6469
- type
- EXPERIMENTAL
- label
- 7 Days
- description
- MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days starting 7 days prior to surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who will undergo staged liver resections are included in this study. In these cases, preoperative MEDI6469 will be given prior to the initial procedure. * Patients with small \<3 cm tumors located \>2 cm away from central bile ducts will be considered for either radiofrequency ablation or resection, the choice of which will be determined at the time of surgery. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Laboratory values during preoperative assessment within the protocol specified range * Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy. * No active gastrointestinal bleeding. * No clinical or laboratory coagulopathy * Anticipated lifespan greater than 12 weeks Exclusion Criteria: * Metastatic disease outside of the liver that is not considered surgically resectable or curable. * Active infection. * Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire. * Previous treatment with mouse monoclonal antibodies. * Need for chronic maintenance oral steroids. * Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures. * Enrollment in a clinical trial in which a different investigational agent is administered within 4 weeks prior to the first dose of MEDI6469.
References
Publications (0)
Data not yet available