stop_circleTerminated/Withdrawn

Neoplasms

Dose-escalation study of Lupartumab Amadotin (BAY1129980)

Trial purpose

The purpose of this study is to evaluate:
- The side effects of BAY1129980 when given every 21 days different dose levels.
- Determine the dose level of BAY1129980 that should be tested in future clinical research studies.
- Measure how much BAY1129980 is in the blood at specific times after administration.
- If treatment with BAY1129980 shows any effect on reducing the tumor growth.
- If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not.
- If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
69
Trial Dates
May 2014 - August 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Lupartumab Amadotin (BAY1129980)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Nashville, 37203, United States
Completed
Buffalo, 14263, United States
Completed
Houston, 77030, United States
Completed
Dallas, 75230, United States
Completed
Washington, 20007-2113, United States
Completed
La Jolla, 92093, United States
Withdrawn
Chicago, United States
Withdrawn
Orlando, 32806, United States
Completed
Gainsville, 32610, United States
Completed
New York, United States
Withdrawn
Los Angeles, 90089, United States
Completed
Aurora, 80045, United States
Completed
Seattle, 98109-1023, United States
Completed
Westwood, 66205, United States
Completed
Durham, 27708, United States
Withdrawn
Hamilton, L8V 5C2, Canada
Withdrawn
London, N6A 4L6, Canada
Withdrawn
Edmonton, T6G 1Z2, Canada
Completed
Stanford, 94305, United States
Completed
Philadelphia, 19104, United States
Completed
Hackensack, 07601, United States

Primary Outcome

  • Maximum tolerated dose (MTD)
    MTD is defined as the maximum dose at which the incidence of DLTs (dose limiting toxicities) during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalation.
    date_rangeTime Frame:
    21 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • C4.4a expression levels in tumour tissue as measured by immunohistochemistry (IHC)
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response evaluation following RECIST 1.1 criteria
    date_rangeTime Frame:
    Up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration of BAY1129980 characterized by AUC (0-tlast)
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    No
  • Antidrug and antibody titer
    date_rangeTime Frame:
    Baseline and up to 2 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label Phase I dose-escalation study to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-C4.4a antibody drug conjugate BAY1129980 in subjects with advanced solid tumors known to express C4.4a
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1