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First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin

NCT03507452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection:

* safety (to identify, assess, minimize, and appropriately manage the risks associated to the study drug)
* tolerability (the degree to which side effects can be tolerated by your body)
* maximum tolerated dose
* pharmacokinetics (the effect of your body on the study drug)
* anti-tumor activity
* recommended dose for further clinical development

Conditions

  • Advanced Recurrent Malignant Pleural Epithelioid Mesothelioma
  • Advanced Recurrent Malignant Peritoneal Epithelioid Mesothelioma
  • Advanced Recurrent Serous Ovarian Cancer
  • Advanced Pancreatic Ductal Adenocarcinoma (Optional, Dose Expansion, Not Initiated)

Interventions

DRUG

BAY2287411

Dose Escalation part: A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).

DRUG

BAY2287411

Dose Expansion part: The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-13
Primary Completion
2021-09-29
Completion
2022-03-29
FDA Drug
Yes

Countries

  • United States
  • Finland
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT03507452 on ClinicalTrials.gov