CompletedPhase 1

Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors

United Kingdom43 participantsStarted 2008-11

Plain-language summary

The main purpose of this study is to determine whether, GL-ONC1, an Oncolytic Virus, can safely be administered intravenously in patients with advanced solid tumors.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosis of histologically or cytologically documented, advanced stage solid tumor (e.g., primary or metastatic breast, prostate or colorectal cancer) refractory to standard therapy or for which no curative standard therapy exists.
✓. Evidence of measurable or evaluable disease.
✓. Disease that can be safely serially biopsied.
✓. Circulating tumor cell count \> 10 for analyses of tumor cell viral delivery.

What they're measuring

Determine the safety and tolerability of GL-ONC1, administered intravenously to patients with advanced solid tumors.

Timeframe: Every 30 minutes for 2 hours after each administration of GL-ONC1, then daily until discharge and on day 8, then weekly up to day 21, then week 12 and week 24

Trial details

NCT IDNCT00794131

SponsorGenelux GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11

View on ClinicalTrials.gov More Advanced Cancers (Solid Tumors) trials