Clinical trial · Interventional
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.
NCT01800812CI-TRIAL-00009603OM-174completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injections of OM-174 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The occurrence of any adverse event
- timeFrame
- up to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDIsambert N, Fumoleau P, Paul C, Ferrand C, Zanetta S, Bauer J, Ragot K, Lizard G, Jeannin JF, Bardou M. Phase I study of OM-174, a lipid A analogue, with assessment of immunological response, in patients with refractory solid tumors. BMC Cancer. 2013 Apr 2;13:172. doi: 10.1186/1471-2407-13-172. PMID 23547558