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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 1 Study of MORAb-004 in Patients With Solid Tumor

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: MORAb-004


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Provide written informed consent, Japanese male and female subjects aged at 20 or older at informed consent, Have malignant solid tumor, without intracranial involvement or metastasis, diagnosed by standard pathology criteria that has failed or are resistant to standard chemotherapy, Performance status (PS) is 0 to 1 by Eastern Cooperative Oncology Group, 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, Survival expectation is 12 weeks or longer after starting MORAb-004 administration Exclusion criteria: Have clinically significant cardiovascular disease, Scheduled for laparotomic surgery due to trauma or other reasons for during the study, Have clinically significant hemorrhagic event or history, or event with high risk of hemorrhage, Receiving chronic systemic anticoagulation, Have evidence of other active invasive malignancy Females who are lactating or pregnant at Screening or Baseline

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORAb-004<br> | Drug: MORAb-004<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and Safety | Tolerability and the safety profile of multiple intravenous (IV) infusions of MORAb-004 in Japanese participants with solid tumors. | Up to 30 months | 

Secondary Outcome Measures

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