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

NCT03118349 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-04-21

No results posted yet for this study

Summary

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).

Conditions

  • Pancreatic Carcinoma
  • Tumors That Express CA 19-9

Interventions

DRUG

MVT-1075

MVT-1075 administered in two fractions, with each administration of MVT-1075 preceded by blocking dose of MVT-5873.

DRUG

MVT-5873

MVT-5873 administered intravenously as a non-radioactive blocking agent prior to administration of MVT-1075.

Sponsors & Collaborators

  • BioNTech Research & Development, Inc.

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-04-11
Completion
2018-04-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03118349 on ClinicalTrials.gov