A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors
Condition: Neoplasms
Intervention: IMC-3C5
Intervention description: Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Solid Tumors

Summary:

      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.
    

Eligibility criteria:

        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