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

A Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacology of VTX-2337 When Administered to Adult Subjects With Advanced Solid Tumors or Lymphoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688415

Enrollment

Registered

2008-06-03

Start date

2008-11-07

Completion date

2010-11-30

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors, Lymphoma

Brief summary

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.

Interventions

DRUGVTX-2337

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Other specific eligibility criteria may apply. Examination by the investigator is necessary to fully determine eligibility. 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

Design outcomes

Primary

Measure	Time frame
Safety and identification of dose-limiting toxicities	Study duration
Pharmacokinetics	First dose of investigational drug

Secondary

Measure	Time frame
Pharmacodynamics	Study duration
Identification of the MTD	First cycle of investigational drug

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026