A Phase II, Open Label, Multiple Center Study of huC242-DM4 Given as an Intravenous Infusion Once Every Three Weeks to Patients With Metastatic Gastric or Gastroesophageal Junction Carcinomas
- Patients must understand and voluntarily sign an informed consent.
- Patients must have histological documentation of metastatic or locally advanced
(American Joint Committee on Cancer Staging System: Stages IIIA, IIIB, and IV)
gastric or gastroesophageal junction adenocarcinoma.
- Patients must have ECOG performance status < 1.
- Patients must be at least 18 years of age.
- Patients who have been treated with only one prior chemotherapy regimen and who have
documented disease progression.
- Patients must have confirmation of CanAg expression performed prior to enrollment by
immunohistochemical assessment for CanAg on archived biopsy samples.
- Patients must have measurable disease with at least one lesion that can be accurately
measured by Response Evaluation Criteria in Solid Tumors (RECIST). The lesion size
must be at least 20 mm by conventional radiological techniques or at least 10 mm by
spiral CT scan. Disease in an irradiated field as the only site of measurable disease
is acceptable if there has been a clear progression of the lesion.
- Patients with reproductive potential must agree to use an effective contraceptive
method during the study and for 30 days after receiving the last dose of study drug.
- Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy
test within one week prior to enrollment in the study.
- Patients must have any chemotherapy, immunotherapy, hormonal therapy, radiotherapy
for cancer or surgery (except for minor surgical procedures) completed at least 3
weeks before starting study medication.
- Patients must have resolution of all clinically significant toxic effects (excluding
alopecia) of any prior treatments including surgery, radiotherapy, hormone therapy,
immunotherapy, targeted non-cytotoxic therapy, or chemotherapy to grade ≤ 1 by NCI
CTCAE v. 3.0 unless otherwise specified in the inclusion laboratory values.
- Patients must have adequate organ function including:
i. Absolute neutrophil count > 1,500/mm3. ii. Platelet count > 100,000/mm3. iii.
Hemoglobin > 9 g/dL (transfusion allowed).
i. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) ii. Calculated
creatinine clearance > 60 mL/min/1.73m2.
i. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 2.5 x
ULN ii. Total bilirubin ≤ 1.5 x ULN
- Pregnant or lactating women. Women of childbearing potential (WCBP) must have a
negative urine or blood test for pregnancy before first treatment.
- Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids.
- Active and uncontrolled infection.
- Known history hepatitis B or C, HIV, or history of alcoholic liver disease.
- Patients with any serious medical or psychiatric disorder that would interfere with
patient safety or informed consent.
- Patients with peripheral neuropathy grade 2 or greater.
- Patients with known leptomeningeal disease or progressive brain metastasis. Routine
screening with CNS imaging studies (CT or MRI) is required only if clinically
- Patients with concomitant malignancies or previous malignancies with less than a 2
year disease free interval at the time of dosing. Patients with adequately treated
basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or
Stage A low-grade prostate cancer may enroll irrespective of the time of diagnosis.
- Patients who are receiving concomitant chemotherapy, immunotherapy, radiotherapy, or
investigational therapy. Radiotherapy for palliation of related bone metastases is
permitted upon the agreement between the investigator and the ImmunoGen Medical
Monitor and as long as radiation does not involve target lesions that are followed
for drug treatment response evaluation.
- Patients with any severe concurrent disease or condition, which in the judgment of
the Investigator, would make the patient inappropriate for study participation. The
disease or condition include, but are not limited to, one or more of the following:
bleeding diathesis, uncontrolled chronic kidney or liver disease, uncontrolled
diabetes, history of cardiac disease, myocardial infarction within the past 6 months,
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and
- Patients who must use contact lenses and cannot discontinue use of their contact
lenses during the course of the clinical study. Patients must discontinue use of
contact lenses prior to receiving study drug.