Phase I Study of Anti-Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Monoclonal Antibody IMC-3G3 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom no Standard Therapy is Available
1. Histopathological-documented, measurable, or non measurable, advanced primary tumor
or recurrent solid tumor or lymphoma unresponsive to standard therapy or for which
there is no standard therapy available.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study
3. Able to provide written informed consent.
4. Age 18 years or older.
5. Life expectancy of > 3 months.
6. Adequate hematologic function, as defined by: an absolute neutrophil count ≥
1500/mm3; a platelet count ≥ 100,000/mm3
7. Adequate hepatic function, as defined by: a total bilirubin level ≤ 1.5 x the upper
limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT)
levels ≤ 2.5 x the ULN or ≤ 5 x the ULN if known liver metastases
8. Adequate renal function, as defined by serum creatinine level ≤ 1.5 x the ULN.
9. Uses effective contraception (per the institutional standard), if procreative
10. Adequate recovery from recent surgery, chemotherapy, and radiation therapy.
11. Accessible for treatment and follow-up, must be treated at the participating center.
1. Received chemotherapy or therapeutic radiotherapy 28 days prior to the first dose of
study medication or has ongoing side effects ≥ grade 2 due to agents administered
more than 28 days earlier.
2. Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection requiring parenteral antibiotics; symptomatic congestive heart failure;
unstable angina pectoris, angioplasty, stenting, or myocardial infarction 6 months
prior to the first dose of study medication; uncontrolled hypertension; clinically
significant cardiac arrhythmia including but not limited to: multifocal premature
ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is
symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia;
uncontrolled diabetes; psychiatric illness/social situations that would compromise
patient safety or limit compliance with study requirements
3. Progressive or symptomatic brain metastases
4. Has a serious or nonhealing active wound, ulcer, or bone fracture.
5. Known human immunodeficiency virus positivity.
6. Major surgical procedure, an open biopsy, or a significant traumatic injury 28 days
prior to treatment.
7. Is currently or has recently used (28 days prior to) a thrombolytic agent.
8. Currently using full-dose warfarin (an exception is low-dose warfarin to maintain
patency of pre-existing, permanent, indwelling intravenous [I.V.] catheters; for
patients receiving warfarin, the international normalized ratio [INR] should be <
1.5). A patient requiring heparin is excluded.
9. Undergoes chronic daily treatment with aspirin (> 325 mg/day) or nonsteroidal
anti-inflammatory medications known to inhibit platelet function (cyclooxygenase-2
[COX-2] inhibitors are permitted).
10. Has a history or clinical evidence of a deep venous or arterial thrombosis (including
pulmonary embolism) 6 months prior to the first dose of study medication.
11. Has proteinuria ≥ 2+ by routine urinalysis
12. Pregnancy (confirmed by serum beta human chorionic gonadotropin) or lactating
13. Received prior treatment with agents targeting the PDGFR ligand or receptor 6 weeks
prior to the first dose of study medication.
14. Received prior treatment with monoclonal antibodies 6 weeks prior to the first dose
of study medication.
15. Has a history of allergic reactions to monoclonal antibodies or other therapeutic