An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable
- The patient has given informed consent.
- The patient is willing and able to abide by the protocol.
- The patient has cancer and curative therapy is unavailable.
- The patient is at least 18 years old.
- The patient has adequate ability to perform activities of daily living.
- Significant toxicities from prior therapy must have recovered.
- The patient has adequate organ function as assessed by laboratory test.
- The patient weighs more than 264 lbs.
- The patient has a known allergy to gentamicin
- The patient has had prior treatment with high-dose chemotherapy requiring stem cell
- The patient is currently on treatment on another therapeutic clinical trial or has
received an investigational agent within 4 weeks prior to first dose with study drug
- The patient has had prior surgery (including open biopsy), radiation therapy or
systemic therapy within 4 weeks of starting the study treatment
- The patient has hypertension > 160/90
- The patient has a history of CNS cancer
- The patient has an unstable medical condition including, but not limited to, cardiac
disease, history of stroke, active hepatitis, or significant pericardial, pleural or
- The patient received recent thrombolytic or anticoagulant therapy
- The patient has lung cancer with central chest lesions
- The patient has had hemorrhage or unhealed wounds within 30 days of dosing
- The patient has used systemic corticosteroids within 3 months of dosing
- The patient has known HIV/AIDS
- The patient has a history of hypersensitivity reaction to human or mouse antibody
- The patient is pregnant or breastfeeding.
- The patient has a history of peptic ulcer disease or gastritis within 6 months of
dosing, unless complete resolution has been documented by esophagogastroduodenoscopy
(EGD) within 30 days of dosing