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

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 TRC093 antibody.

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

Official Title
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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

Conditions
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Cancer, Neoplasm Metastasis

Intervention / Treatment
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* Drug: TRC093 recombinant humanized IgG1k monoclonal antibody


Participation Criteria
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Eligibility Criteria
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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.

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: TRC093 recombinant humanized IgG1k monoclonal antibody|TRC093 is a humanized monoclonal antibody to cleaved collagen administered i.v. on days 1 and 15 of each 28 day cycle until pregression 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 TRC093 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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Phase 1, TRC093, denatured collagen, solid tumor, antibody, TRACON, Locally advanced solid tumors, Metastatic solid tumors