Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy

Inclusion Criteria

• Signed, informed consent
• Age 18 or more years
• Histologically or cytologically confirmed, previously treated, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
• Prior treatment with (or intolerance to) at least one standard systemic regimen for the patient's respective tumor
• Evidence of tumor expression of CA19-9 based on immunohistochemistry performed on tumor samples or elevated serum levels (≥1.5 x upper limits of normal [ULN]) of CA19-9 considered secondary to tumor
• Evaluable or measurable disease based on RECIST 1.1
• Recovered from any prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with prior approval of the Medical Monitor
• If previously exposed to irradiation, the combined prior and anticipated exposure for Cycle 1 is not expected to exceed organ exposure limits outlined in the study protocol
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or Karnofsky performance status (KPS) of 100% to 80%
• Adequate hematologic, renal and hepatic laboratory parameters
• Willingness to participate in collection of pharmacokinetic samples
• Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of MVT-5873 or MVT-1075 (whichever is later)

Exclusion Criteria

• Brain metastases unless previously treated and well controlled for at least 3 months
• Any tumor mass greater than 10 cm in longest diameter
• Other known active cancer(s) likely to require treatment in the next two years
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Prior radiation therapy encompassing more than 25% of the skeleton or prior treatment with 89Strontium or 153Samarium
• Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation except for:
• Ongoing hormonal therapy administered for control of cancer (e.g., breast cancer, prostate cancer), which may be continued throughout the study
• MVT-5873 and MVT-2163 administered as part of a different protocol
• Major surgery other than diagnostic surgery within 28 days of Study Day 1
• History of anaphylactic reaction to human, or humanized, antibody
• Pregnant or currently breast-feeding
• Known to be positive for human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Significant cardiovascular risk including, but not limited to, recent (within 4 weeks) coronary stenting or myocardial infarction within 6 months