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

An Open Label Phase 1 Dose Finding Study of TRC105 in Patients With Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable

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

Study Overview

• Status: Completed
• Conditions: Cancer; Neoplasm Metastasis
• Intervention / Treatment: Drug: TRC105 chimeric anti-CD105 antibody

Detailed Description

In addition to safety, this study will also evaluate pharmacokinetics, tumor response and anti-TRC105 antibody formation.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
  • California
    • Santa Monica, California, United States, 90404
  • New York
    • Buffalo, New York, United States, 14263
  • North Carolina
    • Durham, North Carolina, United States, 27705

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose Limiting Toxicities	28 day evaluation period
Safety and Tolerability will be evaluated	Through last patient last visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of TRC105 monoclonal antibody	through last patient last visit
Number of responses by tumor type	through last patient last visit

Collaborators and Investigators

• Sponsor: Tracon Pharmaceuticals Inc.
• Investigators: Study Director: Bryan R Leigh, MD, Tracon Pharmaceuticals Inc.

Publications and helpful links

General Publications

• Seon BK, Haba A, Matsuno F, Takahashi N, Tsujie M, She X, Harada N, Uneda S, Tsujie T, Toi H, Tsai H, Haruta Y. Endoglin-targeted cancer therapy. Curr Drug Deliv. 2011 Jan;8(1):135-43. doi: 10.2174/156720111793663570.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 28, 2007

Study Record Updates

• Last Update Posted (Estimate): March 5, 2012
• Last Update Submitted That Met QC Criteria: March 2, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Cancer; Phase 1; Solid Tumor; TRC105; CD105; Tracon; Anti CD105
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 105ST101