Clinical trial · Interventional
A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
NCT00869388CI-TRIAL-00011356completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rBBX-01 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
- interventionNames
- Biological: rBBX-01
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
- interventionNames
- Biological: rBBX-01
- type
- EXPERIMENTAL
- label
- Arm 3
- description
- rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDBasche M, Gustafson DL, Holden SN, O'Bryant CL, Gore L, Witta S, Schultz MK, Morrow M, Levin A, Creese BR, Kangas M, Roberts K, Nguyen T, Davis K, Addison RS, Moore JC, Eckhardt SG. A phase I biological and pharmacologic study of the heparanase inhibitor PI-88 in patients with advanced solid tumors. Clin Cancer Res. 2006 Sep 15;12(18):5471-80. doi: 10.1158/1078-0432.CCR-05-2423. PMID 17000682
- BACKGROUNDHayashi N, Kinoshita H, Yukawa E, Higuchi S. Pharmacokinetic and pharmacodynamic analysis of subcutaneous recombinant human granulocyte colony stimulating factor (lenograstim) administration. J Clin Pharmacol. 1999 Jun;39(6):583-92. doi: 10.1177/00912709922008191. PMID 10354962
- BACKGROUNDRosenberg B, Juckett DA, Aylsworth CF, Dimitrov NV, Ho SC, Judge JW, Kessel S, Quensen J, Wong KP, Zlatkin I, Zlatkin T. Protein from intestinal Eimeria protozoan stimulates IL-12 release from dendritic cells, exhibits antitumor properties in vivo and is correlated with low intestinal tumorigenicity. Int J Cancer. 2005 May 1;114(5):756-65. doi: 10.1002/ijc.20801. PMID 15609305
- BACKGROUNDRader JS, Aylsworth CF, Juckett DA, Mutch DG, Powell MA, Lippmann L, Dimitrov NV. Phase I study and preliminary pharmacology of the novel innate immune modulator rBBX-01 in gynecologic cancers. Clin Cancer Res. 2008 May 15;14(10):3089-97. doi: 10.1158/1078-0432.CCR-07-4250. PMID 18483376