Effects of OM-174 in Adult Patients With Solid Tumors

Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01800812

Acronym

OM-174

Enrollment

Registered

2013-02-28

Start date

2007-03-31

Completion date

Unknown

Last updated

2013-02-28

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

Conditions

Solid Tumors

Brief summary

Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.

Interventions

BIOLOGICALInjections of OM-174

Study design

Allocation

NON_RANDOMIZED

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed. * At least one month since the last chemotherapy * Life expectancy above 3 months * Written informed consent * Age above 18

Exclusion criteria

* Patient's refusal * Infection * Brain metastasis * Autoimmune disease * Regular use of steroids * Patient included in another protocol * Chemotherapy or radiotherapy less than 6 weeks ago * Immunotherapy less than 8 weeks ago

Design outcomes

Primary

Measure	Time frame
The occurrence of any adverse event	up to 8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026