A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
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|
- Tolerability and Safety [ Time Frame: Up to 30 months ] [ Designated as safety issue: Yes ]Tolerability and the safety profile of multiple intravenous (IV) infusions of MORAb-004 in Japanese participants with solid tumors.
- Maximum Tolerated Dose (MTD)- Part I [ Time Frame: Up to 30 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773434
|Chikusa-ku, Aichi, Japan|
|Kashiwa, Chiba, Japan|
|Nagaizumi-cho, Shizuoka, Japan|
|Chuo-ku, Tokyo, Japan|
|Study Director:||Ryo Nakajima||Eisai Co., Ltd.|