NCT01527136

Entolimod in Treating Patients With Locally Advanced or Metastatic Solid Tumors That Cannot Be Removed By Surgery

A Phase 1 Study to Evaluate the Safety and Pharmacokinetic Profile of CBLB502 in Patients With Advanced Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of entolimod in treating patients with locally advanced or metastatic solid tumors that cannot be removed by surgery. Biological therapies, such as entolimod, may stimulate the immune system in different ways and stop tumor cells from growing.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety, tolerability, and maximum tolerated dose (MTD) of CBLB502 (entolimod) in patients with advanced cancers. SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	entolimod	Given IM or SC
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-02-06
• Last updated: 2022-07-22

Locations

1 site across 1 country: United States