CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Clostridium novyi-NT sporesbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01924689
NCT01924689Phase 1Completed
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Phase I Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies

BioMed Valley Discoveries, Inc·interventional·Posted Aug 16, 2013·Updated Sep 9, 2019

In Brief

A Phase 1 clinical trial evaluating Clostridium novyi-NT spores for Solid Tumor Malignancies. Completed, enrolled 24 participants across 5 sites.

Detailed Summary

This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients with treatment-refractory solid tumor malignancies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor Malignancies
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 16, 2013
Enrollment StartOct 1, 2013
Primary CompletionOct 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.9 years ago

Interventions

Clostridium novyi-NT sporesbiological

Phase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 x 10(4) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(4) spores/kg.