Cancer, Neoplasm Metastasis
Conditions
Keywords
Phase 1, TRC093, denatured collagen, solid tumor, antibody, TRACON, Locally advanced solid tumors, Metastatic solid tumors
Brief summary
This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.
Detailed description
In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation.
Interventions
DRUGTRC093 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.
Sponsors
Tracon Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient will be eligible for study participation only if all of the following criteria apply: 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 apply: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be evaluated | Through last patient last visit |
| Dose Limiting Toxicities | 28 day evaluation period |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of TRC093 monoclonal antibody | Through last patient last visit |
| Number of responses by tumor type | Through last patient last visit |
Countries
United States
Outcome results
None listed