Study of MBP-426 in Patients With Second Line Gastric, Gastroesophageal, or Esophageal Adenocarcinoma

Inclusion Criteria

• •Phase Ib:
• •1. Advanced or metastatic solid tumor malignancy that is refractory to STD therapy, or that has relapsed after STD therapy, or for which conventional therapy is not reliably effective, or no effective therapy is available.
• •2. Measurable disease as defined by RECIST. If recurrence is documented following radiation therapy, the recurrence must have occurred outside the radiation field. Lesions which are located within a previously irradiated field are not considered measurable.
• •3. Age ≥18.
• •4. ECOG performance status: 0, 1 or 2.
• •5. Adequate organ and system function:
• •* Bone marrow: ANC ≥1500/mm3, platelet count ≥100000/mm3, and Hb ≥9 g/dL;
• •* Coagulation: PT \<1.3 x ULN, PTT \>LLN, \<1.1 x ULN
• •* Renal: Serum creatinine of ≤1.5 x the institution's ULN or calculated creatinine clearance ≥60 mL/min/1.73m2;
• •* Hepatic: Total bilirubin ≤1.5 mg/dL, ALT and AST ≤2.5 x ULN (or 5 x ULN), and ALP ≤2.5 x ULN (or 5 x ULN).
• •6. Recovered to ≤Gr 1 from all acute toxicities caused by prior cancer therapies except for residual toxicities which do not pose an ongoing medical risk.
• •7. If of childbearing potential, agree to use an effective method of contraception prior to study entry, for the duration of the study, and for 30 days after the last dose of MBP-426 with FA/5-FU. A negative pregnancy test must be documented at baseline. Patients may not breastfeed while in this study.
• •8. Have the ability to maintain a central IV access.
• •9. Able to comply with the protocol treatments and procedures.
• •10. Provide written informed consent indicating that they are aware of the investigational nature of this study and in keeping with the institution's policies.
• •Phase II:
• •1. Inoperable, histologically, or cytologically confirmed, locally advanced or metastatic gastric, GE junction, or esophageal adenocarcinoma that has recurred or progressed following 1 prior chemotherapy.
• •2. Measurable disease as defined by RECIST. If recurrence is documented following radiation therapy, the recurrence must have occurred outside the radiation field. Lesions which are located within a previously irradiated field are not considered measurable.
• •3. ECOG performance status: 0 or 1.
• •4. Identical to criteria numbers 3-10 for Phase Ib portion of the study.