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

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

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

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

Conditions
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Cancer, Neoplasm Metastasis

Intervention / Treatment
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* Drug: TRC105 chimeric anti-CD105 antibody


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TRC105 chimeric anti-CD105 antibody|TRC105 is a human/murine chimeric IgG1 antibody administered i.v. every two weeks (on days 1 and 15) or weekly (on days 1, 8, 15 and 22) of each 28 day cycle; until progression or unacceptable toxicity develops.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracon, CD105, Anti CD105, TRC105, Phase 1, Cancer, Monoclonal antibody, Solid Tumor