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A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)

This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. ) Identifier:
First received: January 17, 2013
Last updated: November 8, 2016
Last verified: November 2016

This is a multicenter, multiple doses, open-label Phase 1 study of MORAb-004 in subjects with solid tumors. Subjects may have any solid tumor without intracranial involvement or metastases that has failed standard chemotherapy.

This study will be conducted in 2 parts: 1) Part 1 will be the dose escalation portion of this study to assess the tolerability and the safety profile of MORAb-004. Dose will escalate in different cohorts as follows: 2, 4, 8 and 12 mg/kg weekly dosing each as a 4-week cycle with no intra-subject escalation. Individual participants may have additional cycles at the same dose until disease progression unless the participants meet the discontinuation criteria.

2) Part 2 will comprise cohort expansions to further characterize the safety and tolerability of MORAb-004 and to assess preliminary efficacy and the pharmacokinetic/pharmacodynamic relationship of MORAb-004 in gastric cancer and hepatocellular carcinoma (HCC). Three dose levels will be expanded based on the safety profile that was obtained in the dose escalation portion of this study (Part 1): 4 mg/kg (administered on a weekly basis), 8 mg/kg (administered on a weekly basis) and 12 mg/kg (administered every OTHER week).

Condition Intervention Phase
Solid Tumor Drug: MORAb-004 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MORAb-004 in Patients With Solid Tumor

Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • Tolerability and Safety [ Time Frame: Up to 30 months ]
    Tolerability and the safety profile of multiple intravenous (IV) infusions of MORAb-004 in Japanese participants with solid tumors.

Secondary Outcome Measures:
  • Maximum Tolerated Dose (MTD)- Part I [ Time Frame: Up to 30 months ]
    Maximum tolerated dose (MTD) as defined by dose limiting toxicities (DLTs) within the administered range.

  • Optimal Biologic Dose (OBD)- Part II [ Time Frame: Up to 30 months ]

Enrollment: 46
Study Start Date: December 2012
Study Completion Date: October 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MORAb-004 Drug: MORAb-004

MORAb-004 5 mg/mL is administered as an intravenous infusion (IV) in an escalating dose design and will not be escalated or de-escalated in individual participants.

Part 1 (Dose escalation): 4 weekly administrations of 2, 4, 8, and 12 mg/kg in four different cohorts on Days 1, 8, 15, and 22 of a 4-week cycle (28 days).

Part 2 (Cohort expansion): 4 and 8 mg/kg on Days 1, 8, 15, and 22 of a 4-week cycle (28 days) and 12 mg/kg biweekly administration on Days 1 and 15 of a 4-week cycle in different cohorts. The dosages in Part 2 can be amended considering the results of Part 1.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Provide written informed consent,
  2. Japanese male and female subjects aged at 20 or older at informed consent,
  3. Have malignant solid tumor, without intracranial involvement or metastasis, diagnosed by standard pathology criteria that has failed or are resistant to standard chemotherapy,
  4. Performance status (PS) is 0 to 1 by Eastern Cooperative Oncology Group,
  5. With no carry-over effect and no adverse drug reaction of prior treatment which may affect the safety evaluation of MORAb-004, except for Grade 1 or 2 neuropathy and alopecia,
  6. Survival expectation is 12 weeks or longer after starting MORAb-004 administration

Exclusion criteria:

  1. Have clinically significant cardiovascular disease,
  2. Scheduled for laparotomic surgery due to trauma or other reasons for during the study,
  3. Have clinically significant hemorrhagic event or history, or event with high risk of hemorrhage,
  4. Receiving chronic systemic anticoagulation,
  5. Have evidence of other active invasive malignancy
  6. Females who are lactating or pregnant at Screening or Baseline
  Contacts and Locations
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Please refer to this study by its identifier: NCT01773434

Chikusa-ku, Aichi, Japan
Kashiwa, Chiba, Japan
Nagaizumi-cho, Shizuoka, Japan
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Ryo Nakajima Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Co., Ltd. Identifier: NCT01773434     History of Changes
Other Study ID Numbers: MORAb-004-J081-103
Study First Received: January 17, 2013
Last Updated: November 8, 2016 processed this record on June 22, 2017