Safety and Pharmacologic Study of VTX-2337 in Patients With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-07

Study Completion Date

2010-11-30

Brief Summary

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This is a multi-center, Phase I study of a new investigational drug, VTX-2337, that may stimulate the immune system to help fight cancer. The purpose of the study is to assess the safety of the investigational drug and to identify the highest dose that is well-tolerated. The pharmacology of VTX-2337 will also be evaluated.

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Detailed Description

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Conditions

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Advanced Solid Tumors Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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VTX-2337

Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ability and willingness to provide written informed consent
* Histologically or cytologically confirmed solid tumors or lymphoma
* Locally advanced or metastatic disease
* Life expectancy of at least 16 weeks
* ECOG performance status of 0 or 1
* Acceptable physical exam and laboratory tests at study entry
* Willingness to use medically acceptable contraception
* A negative serum pregnancy test for women with reproductive potential

Exclusion Criteria

* Anticancer therapy within 2 weeks
* Treatment with an investigational agent within 4 weeks
* Systemic corticosteroids within 2 weeks or a requirement for systemic immunosuppressive therapy
* Known brain metastases unless stable for at least 28 days
* Active autoimmune disease
* Insulin-dependent diabetes mellitus
* Clinically significant cardiac disease within 6 months
* Significant infection or fever within 1 week
* Pregnant or breast-feeding females
* Other conditions or circumstances that could interfere with the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No