Clinical Trial · NCT03118349

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

Overview

Open label, nonrandomized, dose-escalation with cohort expansion study of MVT-5873/MVT-1075 in subjects with previously treated, Carbohydrate Antigen 19-9 (CA19-9) positive malignancies (e.g., pancreatic adenocarcinoma).

Sponsor

Hookipa Biotech GmbH

Phase

Phase 1

Contacts

BioNTech Responsible Person (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03118349

Drug / Compound

HuMab-5B1

Isotope(s):

Target(s):

Cancer Antigen 19-9 (CA19-9), specifically the sialyl Lewis A epitope

Ligand Class: Antibodies

Chelator: CHX-A''-DTPA

Eligibility

Inclusion

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
Adequate hematologic, renal and hepatic laboratory parameters
Evaluable or measurable disease based on RECIST 1.1
Prior treatment with (or intolerance to) at least one standard systemic regimen for the patient's respective tumor
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

Exclusion

Prior radiation therapy encompassing more than 25% of the skeleton or prior treatment with 89Strontium or 153Samarium
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
MVT-5873 and MVT-2163 administered as part of a different protocol
Any tumor mass greater than 10 cm in longest diameter
Brain metastases unless previously treated and well controlled for at least 3 months