Trial · Interventional
CompletedPhase 1Registry dataA Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 12 participants (actual)
- Sponsor
- Lytix Biopharma AS · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
Norway
- Start
- Aug 2010
- Primary completion
- Dec 2011
- Completion
- Jan 2012
- First posted
- 18 Oct 2010 (estimated)
- Last update posted
- 11 Jan 2012 (estimated)
- Conditions
- Carcinoma
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
NCT01223209Aug 2010 to Jan 2012
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour. GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start the immune response in the body to have effect of GV-1001. LTX-315, also a peptide, in development for cancer treatment. In this study, the investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating the immune system.
Interventions
- LTX-315Drug
Arms1
Experimental
LTX-315
The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001.
Primary outcomes1
Outcomes the sponsor listed as primary.
Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.
Time frame · 5 injections, treatment period 36 days
Registry description
Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.
Secondary outcomes(1)
To evaluate the safety profile of LTX-315 in combination with GV1001 study
Time frame · 5 injections, treatment period 36 days
Registry description
Assessment of adverse events and abnormal laboratory values recorded during the
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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