Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title: A First-In-Human Phase I Study of sEphB4-HSA in Patients With Advanced Solid Tumors With Expansion at the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D).

Status Terminated

Clinical Trial Summary

This study is about an experimental drug called sEphB4-HSA (recombinant albumin fusion protein sEphB4-HSA). This research study will be the first time sEphB4-HSA is given to people. sEphB4-HSA prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. sEphB4-HSA has shrunk colon, lung, breast, glioma, melanoma, prostate and Kaposi's sarcoma tumors in mice

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of sEphB4-HSA.

II. To describe the dose limiting toxicities and adverse event profile of sEphB4-HSA in patients with advanced solid tumors.

III. To describe the pharmacokinetics of sEphB4-HSA. IV. To describe the anti-tumor activity of sEphB4-HSA as manifested by responses to treatment.

V. To obtain preliminary evaluation of effect of sEphB4-HSA on absolute circulating tumor cell (CTC) numbers as compared with pre-treatment levels using pre- and during treatment CTC. Exploratory evaluation of effect of sEphB4-HSA on downstream protein mediators of the Ephrin pathway (pAKT, pSrc) and their transcriptional target genes (rgs5 and psenen) will be performed.

VI. To collect pilot information to identify a dose or doses with biologic activity. Biologic activity after treatment with sEphB4-HSA will be defined as evidence of drug-on-target effect as manifested by reduction in absolute CTC numbers. Other exploratory evaluations of drug-on-target effect such as increase in transcript levels of psenen or rgs5 may be considered in the assessment of biologic activity.

OUTLINE: This is a dose-escalation study. Patients will be assigned to receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes in one of the following treatment schedules:

1. Weekly treatment - administered on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

2. Every 2 weeks treatment - administered on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

3. Every 3 weeks treatment - administered on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ;

Related Conditions & MeSH terms

• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT01642342
• Study type: Interventional
• Source: University of Southern California
• Status: Terminated
• Phase: Phase 1
• Start date: September 6, 2012
• Completion date: May 29, 2019