A Study of MORAb-009 in Patients With Solid Tumor

A Phase 1 Study of MORAb-009 in Patients With Solid Tumor

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018784

Enrollment

Registered

2009-11-25

Start date

2009-11-30

Completion date

2013-02-28

Last updated

2016-01-21

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

Conditions

Cancer, Mesothelin-positive

Keywords

Cancer, Mesothelin-positive

Brief summary

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.

Interventions

DRUGMORAb-009

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To investigate dose-limiting toxicity and estimate maximum tolerated dose.	4 Weeks

Secondary

Measure	Time frame
The best overall response rate in the RECIST evaluation and the preliminary evaluation calculating the frequency of Completed response and Partial Response.	During Study

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026