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An Open Label Phase 1B Dose-Escalation Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Adult Solid Tumor

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Trial Information

An Open Label Phase 1B Dose-Escalation Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors

Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that
inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor
types. TRC105, a monoclonal antibody to CD105, is a novel angiogenesis inhibitor that
complements bevacizumab in preclinical models. Together, these antibodies may result in
more effective angiogenesis inhibition and improved clinical efficacy over that seen with
bevacizumab alone. The purpose of the study is to evaluate safety and tolerability and
determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in
patients with advanced solid tumors for which bevacizumab is indicated.

Inclusion Criteria:

1. Histologically proven advanced or metastatic solid cancer

2. Measurable disease, evaluable disease or elevation of a relevant soluble tumor marker
(e.g., CEA, PSA, CA125)

3. Age of 18 years or older

4. ECOG performance status of 0 or 1

5. Resolution of all acute AEs resulting from prior cancer therapies to NCI CTCAE Grade
≤ 1 or baseline (except alopecia)

6. Adequate organ function

7. Willing and able to consent for self to participate in study

Exclusion Criteria:

1. Prior treatment with TRC105

2. Serious dose-limiting toxicity related to prior bevacizumab

3. Current treatment on another therapeutic clinical trial

4. Receipt of an investigational agent within 28 days of starting study treatment

5. Prior surgery (including open biopsy) within 28 days of starting the study treatment

6. Prior radiation therapy or systemic therapy within 21 days of starting the study

7. Minor surgical procedures such as fine needle aspirations, Mediport placement or core
biopsies within 7 days of study treatment

8. Uncontrolled chronic hypertension defined as systolic > 140 or diastolic > 90 despite
optimal therapy (initiation or adjustment of BP medication prior to study entry
allowed provided that the average of 3 BP readings at a visit prior to enrollment is
< 140/90 mm Hg)

9. Symptomatic pericardial or pleural effusions

10. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2

11. History of brain involvement with cancer, spinal cord compression, or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease (except in the
expansion cohort at the MTD where brain metastases or primary brain tumors are

12. Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient
ischemic attack, arterial embolism, pulmonary embolism, DVT, PTCA or CABG within the
past 6 months

13. Active bleeding or pathologic condition that carries a high risk of bleeding

14. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days
prior to first day of study therapy

15. Cardiac dysrhythmias of NCI CTCAE Grade ≥ 2 within the last 28 days

16. Known active viral or nonviral hepatitis

17. Centrally located non-small cell lung cancer (regardless of histologic sub-type), or
non-small cell lung cancer of squamous histology.

18. History of hemorrhage or hemoptysis (>½ teaspoon bright red blood) within 6 months of
starting study treatment

19. Open wounds or unhealed fractures within 28 days of starting study treatment

20. History of peptic ulcer disease or erosive gastritis within the past 6 months, unless
treated for the condition and complete resolution has been documented by
esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment

21. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
related illness

22. Pregnancy or breastfeeding

Type of Study:


Study Design:

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

Outcome Measure:

Determine Maximum Tolerated Dose of TRC105 in Combination with Bevacizumab

Outcome Description:

Safety and dose limiting toxicity will be assessed by dose cohort.

Outcome Time Frame:

1.5 years

Safety Issue:


Principal Investigator

Bryan R Leigh, MD

Investigator Role:

Study Director

Investigator Affiliation:

Tracon Pharmaceuticals Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

March 2014

Related Keywords:

  • Adult Solid Tumor
  • TRC105
  • CD105
  • Endoglin
  • Solid Tumors
  • Avastin
  • Bevacizumab
  • Neoplasms



University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Premiere Oncology Santa Monica, California  90404
Indiana University Simon Cancer Center Indianapolis, Indiana  46202
Pinnacle Oncology Hematology Scottsdale, Arizona  85258