Human Monoclonal Antibody 5B1 With Expansion in Pancreatic Cancer or Other CA19-9 Positive Malignancies

Summary

This study focuses on individuals who have cancer that has tested positive for CA19-9, an antigen (substance that causes an immune response) expressed from pancreatic and other types of cancer. The purpose of the study is to evaluate the safety of an investigational drug called MVT-5873. The study will examine various doses and combinations of the drug to determine which dose is safest in humans. MVT-5873 takes advantage of the body’s own immune system and may help patients at risk for recurrent disease (disease that has returned). Participants may receive MVT-5873 alone or in combination with FOLFIRINOX. FOLFIRINOX is a chemotherapy combination and consists of 4 cancer drugs (leucovorin, irinotecan, oxaliplatin and fluorouracil).

Inclusion Criteria

Signed, informed consent
Age 18 or more years
Histologically or cytologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
Recovered from prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with approval of the Medical Monitor

Signed, informed consent
Age 18 or more years
Histologically or cytologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
Recovered from prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with approval of the Medical Monitor
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100% to 80%
Adequate hematologic, hepatic, and renal function
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
[Group A, C, and Group D Dose Escalation]
Evaluable or measurable disease based on RECISTv1.1
[Group A, C, and D]
Progression following treatment with standard of care for the subject's specific tumor type
[Group C and D Expansion and Group E Escalation and Expansion]
Measurable disease based on RECISTv1.1
[Group C and D Expansion, non-PDAC malignancies]
If serum CA19-9 levels (defined as < 1 U/mL or below the level of detection for institutional test used), subject must have confirmation of CA19-9 expression in their tumor prior to study entry (based on institutional determination of CA19-9)
[Group E]
Candidates for mFOLFIRINOX based on accepted standard of care
[Group F]
Histologically or cytologically confirmed PDAC
Macroscopically complete resection (R0 or R1 resection) performed between ≥21 and ≤84 days prior to C1D1
Baseline scans without evidence of disease (e.g., CT/MRI)
Full recovery from surgery and able to receive chemotherapy
Free of significant nausea and vomiting
No prior radiotherapy or chemotherapy
Brain metastases unless previously treated and well controlled for at least 3 months prior to study day 1
Other known active cancer(s) likely to require treatment in the next two (2) years
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation (except for ongoing hormonal therapy for prostate cancer)
Major surgery within 28 days of Study Day 1
History of anaphylactic reaction to human, or humanized, antibody
Pregnant or currently breast-feeding
Known HIV, Hepatitis B or C-positive
Psychiatric illness/social situations that would interfere with compliance with study requirements
Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)
[Group F]
Incomplete macroscopic tumor removal (R2 resection)
Other known active cancer(s) likely to require treatment in the next 2 years
Active, uncontrolled bacterial, viral, or fungal infection (s) requiring systemic therapy
History of anaphylactic reaction to human, or humanized, antibody
Pregnant or currently breast-feeding
Known HIV, Hepatitis B or C-positive
Psychiatric illness/social situations that would interfere with compliance with study requirements
Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)
Pre-existing neuropathy
Known homozygous for UGT1A1*28 mutation
Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea

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Study Location(s)

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute

More about this Clinical Trial

Full Title

MV-0715-CP-001-01: Phase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 with Expansion in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies

Details

Disease Type/Condition

Anus, Breast, Colon, Other Female Genital, Ovary, Pancreas, Rectum, Stomach

Principal Investigator

Chiu, Vi K.

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Kristopher Wentzel, Michelle Offner, Omid Hamid, Rodolfo Gutierrez

Age Group

Adult

Phase

IRB Number

STUDY00001810