Clinical trial NCT01773434: A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)
Official title: A Phase 1 Study of MORAb-004 in Patients With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Tolerability and Safety
timeFrame: Up to 30 months
Secondary outcomes:
measure: Maximum Tolerated Dose (MTD)- Part I
timeFrame: Up to 30 months
measure: Optimal Biologic Dose (OBD)- Part II
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Chikusa-ku
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Nagaizumi-cho
country: Japan
state: Shizuoka
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Eisai Co., Ltd.
name: Ryo Nakajima
role: STUDY_DIRECTOR
References:
citation: Doi T, Aramaki T, Yasui H, Muro K, Ikeda M, Okusaka T, Inaba Y, Nakai K, Ikezawa H, Nakajima R. A phase I study of ontuxizumab, a humanized monoclonal antibody targeting endosialin, in Japanese patients with solid tumors. Invest New Drugs. 2019 Oct;37(5):1061-1074. doi: 10.1007/s10637-018-0713-7. Epub 2019 Jan 9.