Clinical trial · Interventional
A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors
Phase 1 Study of the Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available
NCT01288989CI-TRIAL-00039101completedPhase 1Results 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)
A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5 in subjects with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMC-3C5 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMC-3C5
- description
- Participants receiving IMC-3C5 intravenously
- interventionNames
- Biological: IMC-3C5
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- Baseline up to 46 months
- description
- AEs include serious AEs (SAEs). AEs do not distinguish whether the events are treatment-emergent. A summary of serious and other non-serious AEs, regardless of causality, is presented in the Reported Adverse Event module.
- measure
- Number of Participants Reporting Dose-Limiting Toxicity (DLT)
- timeFrame
- Baseline up to 16 Months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participant has histologic or cytologic confirmation of cancer 2. Participant has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available 3. Participant has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 4. Participant has not received prior chemotherapy or prior treatment with an investigational agent or device within 28 days prior to enrollment(hormone therapy is acceptable) 5. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2 6. Participant has adequate hematologic, hepatic, renal, and coagulation function 7. Participant has a life expectancy greater than 3 months 8. Participant agrees to use adequate contraception during the study period and for 12 weeks after last dose of investigational agent Exclusion Criteria: 1. Participant has a known sensitivity to monoclonal antibodies or other therapeutic proteins, or to agents of similar biologic composition as IMC-3C5 2. Participant has received treatment with any monoclonal antibodies including bevacizumab within 6 weeks prior to enrollment 3. Participant has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment 4. Participant has an ongoing or active infection (except as outlined in Exclusion Criterion #11), congestive heart failure, active bleeding or any other serious uncontrolled medical disorder 5. Participant has known or suspected untreated brain or leptomeningeal metastases 6. Participant has uncontrolled hypertension 7. Participant has received an organ transplant 8. Participant has a serious or nonhealing wound, ulcer, or bone fracture 9. Participant has experienced an arterial or venous thromboembolic event within 6 months prior to enrollment 10. Participant currently has peripheral edema requiring diuresis or anasarca 11. Participant has Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), except subjects who have been on a stable antiviral regimen for at least 12 weeks, have a viral load of \< 50 copies/mL, and a CD4 count of ≥ 200 cells/mm3 12. Participant is currently using or has received a thrombolytic agent within 28 days prior to enrollment 13. Participant is receiving aspirin at a dose higher than 325 mg per day or full-dose anticoagulation 14. Participant if female, is pregnant or is lactating
References
Publications (1)
- DERIVEDSaif MW, Knost JA, Chiorean EG, Kambhampati SR, Yu D, Pytowski B, Qin A, Kauh JS, O'Neil BH. Phase 1 study of the anti-vascular endothelial growth factor receptor 3 monoclonal antibody LY3022856/IMC-3C5 in patients with advanced and refractory solid tumors and advanced colorectal cancer. Cancer Chemother Pharmacol. 2016 Oct;78(4):815-24. doi: 10.1007/s00280-016-3134-3. Epub 2016 Aug 26. PMID 27566701