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A phase 1 study of MORAb-004 in patients with solid tumor

A phase 1 study of MORAb-004 in patients with solid tumor

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222023
Enrollment
54
Registered
2013-02-19
Start date
2013-02-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumor

Interventions

investigational material(s) Generic name etc : MORAb-004 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Sponsors

Eisai Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Provide written informed consent, 2. Japanese male and female subjects aged 20 or older at informed consent, 3. Have malignant solid tumor, without intracranial involvement or metastasis diagnosed by standard pathology criteria that are resistant to standard chemotherapy, 4. Performance status (PS) is 0-1 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 years or longer after starting MORAb-004 administration

Exclusion criteria

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 Screenint or Baseline

Design outcomes

Primary

MeasureTime frame
Tolerability and safety

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026