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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: MORAb-004

• Registration Number: NCT01773434
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Primary Completion: 2016-07
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MORAb-004	MORAb-004	-

Primary Outcome Measures

Name	Time	Method
Tolerability and Safety	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

Name	Time	Method
Optimal Biologic Dose (OBD)- Part II	Up to 30 months
Maximum Tolerated Dose (MTD)- Part I	Up to 30 months	Maximum tolerated dose (MTD) as defined by dose limiting toxicities (DLTs) within the administered range.