A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors

Study Overview
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Brief Summary
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This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.

Official Title
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A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors

Conditions
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Solid Tumors

Intervention / Treatment
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* Biological: rBBX-01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors preferred. 18 years and above GOG performance status greater than or equal to 2 Life expectancy greater than 6 months Acceptable organ and marrow function Willingness to agree to use adequate contraception prior to study entry and for the duration of study participation Exclusion Criteria: Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse events due to agents administered more than 4 weeks earlier Not receiving any other investigational agents Known brain metastasis Uncontrolled intercurrent illness including, but not limited to ongoing ore active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnancy Immunosuppression including subjects with known HIV infection on immunosuppressive drugs or having an autoimmune disorder Penicillin allergy Symptomatic prostate hypertrophy

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 | Biological: rBBX-01<br> <br> |
| Experimental: Arm 2<br>rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 | Biological: rBBX-01<br> <br> |
| Experimental: Arm 3<br>rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 | Biological: rBBX-01<br> <br> |
| Experimental: Arm 4 (optional)<br>rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 | Biological: rBBX-01<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies. |  | Four bi-weekly 5 day courses | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic and pharmacodynamics of bi-weekly rBBX-01. To correlate the inter-patient sensitivity to rBBX-01 with in vitro studies on patient blood. To describe any anti-tumor activity of rBBX-01. |  | 4 bi-weekly 5 day courses | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant, resistant, solid tumor