The primary objective of this study is to evaluate the tolerability and safety profile of
MORAb-202 in participants with solid tumors.
- Participants who have provided voluntary written consent for participation in this
- Participants to whom the rules for complying with this clinical study have been
adequately explained, and who intend to and can comply with those rules.
- Male or female participants age ≥ 20 years at the time of informed consent of
screening 1 (at screening 2, in case of participants who enter this clinical study
from screening 2).
- Participants with folate receptor α (FRA)-positive solid tumor confirmed by
immunohistochemistry (IHC) at central laboratory using their available tumor samples
from resected specimen (i.e., surgical or excisional/incisional biopsy samples)
- At informed consent of screening 2, participants who failed standard therapies, or for
which no appropriate treatment is available.
- Participants with adequate function of major organs within 2 weeks prior to the first
administration of the study drug as follows.
1. Hemoglobin ≥ 9.0 grams per deciliter (g/dL).
2. Neutrophil count ≥ 1.5 × 10^3/microliters (μL).
3. Platelet count ≥ 10 × 10^4/μL.
4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) in the facility.
5. Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN in the
6. Serum creatinine ≤ 1.5 × ULN in the facility.
7. Albumin ≥ 3 g/dL.
- Participants with Performance Status score of 0-1 established by Eastern Cooperative
- Participants who are expected to survive for 3 months or longer after the first
administration of the study drug.
- Washout period required from the end of prior treatment to the first administration of
the study drug will be as follows
1. Anticancer therapy
- Antibody and other study drugs: > 4 weeks (however, in the case where the
half-life of other study drugs is known and 5 × half-lives of that study
drug is less than or equal to 4 weeks, participants can be eligible after ≥
5 × half-lives of that study drug has passed).
- Prior chemotherapy (except small-molecule targeted therapy), surgical
therapy, radiation therapy: >3 weeks.
- Endocrine therapy, immunotherapy except antibody, small-molecule targeted
therapy: >2 weeks.
2. Supportive therapies • Blood/platelet transfusion, hematopoietic stimulating
agent including granulocyte colony-stimulating factor formulation: > 2 weeks.
- Participants whose formalin fixed, paraffin-embedded unstained slides of tumor sample
must be available for IHC test at central laboratory. Biopsy should be excisional,
incisional or core needle (≤18-gauge).
Inclusion Criteria (Part 2 only)
- Measurable disease meeting the following criteria:
1. At least 1 lesion of ≥ 1.0 centimeters (cm) in the longest diameter for a
non-lymph node or ≥ 1.5 cm in the short-axis diameter for a lymph node that is
measurable according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
using computerized tomography/magnetic resonance imaging.
2. Lesions that have had external beam radiotherapy or locoregional therapies such
as radiofrequency ablation must show evidence of progressive disease based on
RECIST 1.1 to be deemed a target lesion.
Inclusion Criteria (Part 2: triple negative breast cancer [TNBC] cohort only)
- Histologically or cytologically confirmed diagnosis of TNBC.
- Female participants who had received at least an anthracycline or taxane treatment for
the neoadjuvant/adjuvant or chemotherapy for refractory or relapse TNBC and progressed
Inclusion Criteria (Part 2: Type 2 endometrial carcinoma cohort only)
- Histologically or cytologically confirmed diagnosis of Type 2 endometrial carcinoma
(non-estrogen-dependent adenocarcinoma. However, carcinosarcoma and sarcoma are
- Participants who had received at least one prior platinum-based chemotherapeutic
regimen for advanced or metastatic endometrial carcinoma.
- Medical history of clinically significant cardiovascular impairment:
1. Congestive heart failure greater than or equal to New York Heart Association
2. Unstable angina pectoris, myocardial infarction or stroke within 6 months before
of the first administration of the study drug.
3. Prolongation of corrected QT (QTc) interval to > 480 milliseconds (ms)
4. Arrhythmias requiring treatment.
- Concomitant systemic infection requiring medical treatment.
- Participants who test positive for human immunodeficiency virus (HIV antibody).
- Active viral hepatitis (B or C) (*) as demonstrated by positive serology or requiring
(*) hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs)/hepatitis
B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody test. Participants who
are anti-HBs/HBcAb (+) without detectable hepatitis B virus (HBV)-deoxyribonucleic acid
(DNA) are eligible.
- Effusion requiring drainage continually.
- Participants whose toxicity of previous treatment has not recovered to Grade 1 or
lower (except for alopecia).
- Participants who have received a previous monoclonal antibody therapy and have
evidence of an immune or allergic serious reaction.
- Participants who had previous treatment with other folate receptor targeting agents.
- Participants who have medical history of discontinuing prior eribulin due to toxicity.
- Other active malignancy (except for definitively treated melanoma in-situ, basal or
squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the
past 24 months prior to the first administration of the study drug.
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a
positive beta-human chorionic gonadotropin or human chorionic gonadotropin). A
separate baseline assessment is required if a negative screening pregnancy test was
obtained more than 3 days before the first administration of the study drug
(breastfeeding participants are not eligible even if they discontinue breastfeeding).
- Women of childbearing potential or man of impregnate potential who don't agree that
both the participant and his/her partner will use a medically effective method for
contraception (as below) during the study and after study drug discontinuation (male;
90 days, female; 60 days).
Note: Condom*, contraceptive sponge**, foam**, jelly**, diaphragm*, intrauterine device*,
or use of oral contraception* from at least 4 weeks before starting the study treatment
(*Approved drugs or certified medical devices in Japan, **Non-approved drugs or certified
medical devices in Japan).
- Known intolerance to the study drug or any of the excipients.
- Any medical or other condition that in the opinion of the investigator(s) would
preclude the subject's participation in the study.
- Scheduled for surgery during the study.
- Diagnosed with meningeal carcinomatosis.
- Participants with brain or subdural metastases are not eligible, unless they have
completed local therapy and have discontinued the use of corticosteroids for this
indication for at least 4 weeks before starting treatment in this study. Any signs
(e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks
before starting study treatment.
- Use of illegal recreational drugs.