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

NCT01773434 | Completed Phase 1

• 1 other identifier: MORAb-004-J081-103
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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).

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum Tolerated Dose (MTD)- Part I

  Up to 30 months

• Optimal Biologic Dose (OBD)- Part II

  Up to 30 months

Study Arms (1)

MORAb-004

EXPERIMENTAL

Drug: MORAb-004

Interventions

MORAb-004 DRUG

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.

MORAb-004

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Chikusa-ku, Aichi-ken, Japan

Location

Unknown Facility

Kashiwa, Chiba, Japan

Location

Unknown Facility

Nagaizumi-cho, Shizuoka, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 30623276 DERIVED

MeSH Terms

Interventions

ontuxizumab

Study Officials

• Ryo Nakajima

  Eisai Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 23, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

JP (4)