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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00869388

Enrollment

Registered

2009-03-26

Start date

2008-10-31

Completion date

2009-12-31

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

malignant, resistant, solid tumor

Brief summary

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

Interventions

BIOLOGICALrBBX-01

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026