Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Solid Cancer

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being performed to evaluate the safety and tolerability of the TRC105 monoclonal antibody.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tracon Pharmaceuticals Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 rescue

• 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 peritoneal effusion

• 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 products

• 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