Clinical trial · Interventional
A Study of MORAb-003 in Patients With Solid Tumor
A Phase 1 Study of MORAb-003 in Patients With Solid Tumor
NCT01049061CI-TRIAL-00045516completedPhase 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-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing 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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MORAb-003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MORAb-003
- interventionNames
- Drug: MORAb-003
Primary outcomes (1)
- measure
- To investigate dose-limiting toxicity and estimate maximum tolerated dose.
- timeFrame
- 7 weeks
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 aged \>or=20 to \<80 years at obtaining informed consent 2. Patient with histologically or cytologically diagnosed solid tumor 3. Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported) 4. Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have 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 other active malignancy (except for carcinoma in situ) 5. With a large volume of pleural effusion or ascites requiring drainage
References
Publications (1)
- DERIVEDSasaki Y, Miwa K, Yamashita K, Sunakawa Y, Shimada K, Ishida H, Hasegawa K, Fujiwara K, Kodaira M, Fujiwara Y, Namiki M, Matsuda M, Takeuchi Y, Katsumata N. A phase I study of farletuzumab, a humanized anti-folate receptor alpha monoclonal antibody, in patients with solid tumors. Invest New Drugs. 2015 Apr;33(2):332-40. doi: 10.1007/s10637-014-0180-8. Epub 2014 Nov 9. PMID 25380636