Entolimod in Treating Patients With Locally Advanced or Metastatic Solid Tumors That Cannot Be Removed By Surgery
Unspecified Adult Solid Tumor, Protocol Specific
Other: pharmacological study
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study to Evaluate the Safety and Pharmacokinetic Profile of CBLB502 in Patients With Advanced Cancers|
- MTD of entolimod [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]Evaluated using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
- Safety of entolimod [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]Evaluated using NCI-CTCAE Version 4.0.
- Efficacy of entolimod in patients with advanced cancers in terms of objective response rate (ORR) and RECIST response [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]ORR will be calculated as the number of patients with a confirmed complete or partial response divided by the total number of patients. Tumor response will be summarized, and the 95% confidence interval for ORR (complete response [CR] + partial response [PR]) will be presented. Evaluated using the RECIST criteria.
- PK profiles of entolimod in patients with advanced cancers [ Time Frame: Pre-dose, 2, 4, 6, 8, 24 hours, post dose for, days 1, 4, 8 and 11 ] [ Designated as safety issue: No ]
- PD profiles of entolimod in patients with advanced cancers [ Time Frame: PD plasma: pre-dose, at 2, 4 and 6 hours post dose on day 1, 4, 8, 11, 15, 22, and 43 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (entolimod)
Patients receive entolimod IM or SC on days 1, 4, 8, and 11. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Given IM or SC
Other Names:Other: pharmacological study
Correlative studiesOther: laboratory biomarker analysis
I. To determine the safety, tolerability, and maximum tolerated dose (MTD) of CBLB502 (entolimod) in patients with advanced cancers.
I. To assess any preliminary evidence of efficacy with the CBLB502 in patients with advanced cancers.
II. To evaluate pharmacokinetic (PK)/pharmacodynamic (PD) profiles of CBLB502 in patients with advanced cancers.
III. To characterize the effect, if any, of intramuscular or subcutaneous CBLB502 on QTcB.
I. To correlate pre-treatment tissue expression of toll-like receptor 5 (TLR5) with clinical activity (Response Evaluation Criteria In Solid Tumors [RECIST] tumor response) and PD response (as measured by cytokine levels) of CBLB502.
OUTLINE: This is a dose-escalation study.
Patients receive entolimod intramuscularly (IM) on day 1 and subcutaneously (SC) on days 4, 8, and 11. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527136
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Alex Adjei||Roswell Park Cancer Institute|