A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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).