check_circleStudy Completed

Oncology

Phase I study to determine the maximum tolerable dose of BAY94-9343 in patients with advanced solid tumors.

Trial purpose

BAY94-9343 was an antibody-drug conjugate (ADC) directed against the cancer antigen mesothelin on tumor cells.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
148
Trial Dates
September 2011 - July 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Nashville, 37203, United States
Completed
Houston, 77030, United States
Completed
Bethesda, 20892, United States
Completed
Oklahoma City, 73104, United States
Completed
Detroit, 48201, United States
Completed
New Haven, 06520-8063, United States
Completed
Chicago, 60637, United States
Completed
Dallas, 75251, United States
Withdrawn
Minneapolis, 55455, United States

Primary Outcome

  • Incidence of DLT (dose limiting toxicity) of BAY 94-9343
    date_rangeTime Frame:
    At the end of Cycle 1 Day21
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    Safety Issue:
    Yes
  • Determination of the Pharmacokinetic profile of BAY94-9343 and its metabolites (ADC, Total Antibody, DM4 and DM4-Me)
    Q3W Arm: Cmax, AUC (0-504), AUC (0-tlast), tmax, t1/2 and AUC (Cycle 1 only) Q3W: Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, (24), 48, (96), 168, 336 and 504 hours after start of infusion QW Arm:Cmax, AUC(0-168) and tmax) QW: Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48 and 168 hours after start of infusion
    date_rangeTime Frame:
    Cycle 1 and Cycle 3: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, (24), 48, (96), 168, 336 and 504 hours after start of infusion
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    Safety Issue:
    No

Secondary Outcome

  • Biomarker evaluation: Plasma concentrations of soluble mesothelin and Cytokeratin 18 (CK18)
    date_rangeTime Frame:
    C1D1: pre-dose, 24, 48, and 168h after start of infusion; C2D1: pre-dose, 4 and 168h after start of infusion; C3D1: pre-dose, 24, 48, and 168h after start of infusion; C4 and every even cycle: pre-dose until Implementation of Am 6
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    Safety Issue:
    No
  • Tumor response: assessment of best response and PFS (progression free survival) according to RECIST (Response Evaluation Criteria in Solid Tumours) 1.1
    date_rangeTime Frame:
    1 year/Screening; Within 5 days before the end of every even cycle until Cycle 8 (Cycle 2, Cycle 4, etc.); Within 5 days before the end of every 4th cycle after Cycle 8 (Cycle 12, 16, etc.); end of treatment
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    Safety Issue:
    No
  • Immunogenicity assessment: assessment of Anti-drug antibody (ADA) formation and neutralizing antibodies (NAs) against anetumab ravtansine
    date_rangeTime Frame:
    1 year / Cycle 1, 2 and 3 Day 1: pre-dose; Day 1 of every even cycle starting from Cycle 4 (Cycle 4, 6, 8 etc.): pre-dose until implementation of Am 6
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    Safety Issue:
    No
  • Biomarker evaluation - Levels of mesothelin expression in tumor tissue
    date_rangeTime Frame:
    Anytime prior to general screening
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    Safety Issue:
    No

Trial design

An open label Phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of the anti-mesothelin antibody drug conjugate BAY94-9343 in subjects with advanced solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4