Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation.

Inclusion criteria

A patient will be eligible for study participation only if all of the following criteria apply:

• The patient has given informed consent.
• The patient is willing and able to abide by the protocol.
• The patient is at least 18 years old.
• The patient has advanced cancer and is not eligible for treatment or no effective treatment exists.
• Significant toxicities resulting from prior therapy must have recovered.
• If the patient is a female of childbearing potential, she is using an acceptable/effective method of contraception.
• If the patient is a female, she has had a negative serum pregnancy test within the past 30 days.
• The patient has adequate ability to perform activities of daily living.
• The patient has adequate organ function as assessed by laboratory tests

Exclusion criteria

A patient will not be eligible for study participation if any of the following criteria apply:

• The patient weighs more than 264 lbs.
• The patient has had a major surgical procedure, or significant injury within the past 28 days or there is an anticipation of the need for major surgery during the course of the study.
• The patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days.
• The patient has known brain tumors.
• The patient experienced blood clots within six months prior to study start.
• The patient has a non-healing wound, ulcer or bone fracture.
• The patient received recent thrombolytic or anticoagulant therapy.
• The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
• The patient enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
• The patient is receiving, or plans to receive, an anti-cancer therapy during the study with the exception of patients receiving chronic luteinizing hormone-releasing hormone (LHRH) agonists.