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

Phase 1
18 Years
Not Enrolling
Cancer, Neoplasm Metastasis

Thank you

Trial Information

A Phase 1, Open-label, Dose Escalation Study of the Humanized Monoclonal Antibody, 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

1. The patient has given informed consent.

2. The patient is willing and able to abide by the protocol.

3. The patient is at least 18 years old.

4. The patient has advanced cancer and is not eligible for treatment or no effective
treatment exists.

5. Significant toxicities resulting from prior therapy must have recovered.

6. If the patient is a female of childbearing potential, she is using an
acceptable/effective method of contraception.

7. If the patient is a female, she has had a negative serum pregnancy test within the
past 30 days.

8. The patient has adequate ability to perform activities of daily living.

9. 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

1. The patient weighs more than 264 lbs.

2. 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.

3. The patient has received treatment for their cancer, including radiation (minimal
amount of localized radiation may be allowed), within the past 28 days.

4. The patient has known brain tumors.

5. The patient experienced blood clots within six months prior to study start.

6. The patient has a non-healing wound, ulcer or bone fracture.

7. The patient received recent thrombolytic or anticoagulant therapy.

8. 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.

9. The patient enrolled, or plans to enroll, in a concurrent treatment protocol with
another investigational product.

10. 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability will be evaluated

Outcome Time Frame:

Through last patient last visit

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

November 2009

Related Keywords:

  • Cancer
  • Neoplasm Metastasis
  • Phase 1
  • TRC093
  • denatured collagen
  • solid tumor
  • antibody
  • Locally advanced solid tumors
  • Metastatic solid tumors
  • Neoplasms
  • Neoplasm Metastasis



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