Clinical trial · Interventional
A Study of MORAb-009 in Patients With Solid Tumor
A Phase 1 Study of MORAb-009 in Patients With Solid Tumor
NCT01018784CI-TRIAL-00020612completedPhase 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)
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Mesothelin-positive | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MORAb-009 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MORAb-009
- interventionNames
- Drug: MORAb-009
Primary outcomes (1)
- measure
- To investigate dose-limiting toxicity and estimate maximum tolerated dose.
- timeFrame
- 4 Weeks
Secondary outcomes (1)
- measure
- The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response.
- timeFrame
- During Study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion criteria; 1. Japanese male and female patients aged from 20 to less than 80 years at obtaining informed consent 2. Patient with histologically or cytologically diagnosed solid tumor 3. Patient who is mesothelin-positive confirmed by immunohistochemistry (IHC) (except for pancreatic cancer and mesothelioma that mesothelin-positive is frequently reported) 4. Patient with solid tumor who is non responder to or resistant to standard therapy and has no other appropriate treatment 5. Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group ECOG criteria Exclusion criteria 1. Brain metastasis presenting clinical symptoms or requiring medical treatment 2. Serious and systemic infection requiring medical treatment 3. History of hypersensitivity to protein formulations including monoclonal antibody 4. With active multiple carcinoma (except for carcinoma in situ and intramucosal carcinoma) 5. With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a large volume of celomic fluid
References
Publications (1)
- DERIVEDFujisaka Y, Kurata T, Tanaka K, Kudo T, Okamoto K, Tsurutani J, Kaneda H, Okamoto I, Namiki M, Kitamura C, Nakagawa K. Phase I study of amatuximab, a novel monoclonal antibody to mesothelin, in Japanese patients with advanced solid tumors. Invest New Drugs. 2015 Apr;33(2):380-8. doi: 10.1007/s10637-014-0196-0. Epub 2014 Dec 12. PMID 25502863