Title
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
Phase
Phase 1Lead Sponsor
VentiRx Pharmaceuticals Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Advanced Solid Tumors LymphomaIntervention/Treatment
motolimod ...Study Participants
33This 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.
Escalating doses of the investigational drug will be administered to cohorts of patients until the highest tolerated dose is identified.
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
