check_circleStudy Completed

Advanced CEACAM6-expressing solid tumors

Bayer Identifier:

18650

ClinicalTrials.gov Identifier:

NCT03596372

EudraCT Number:

2018-002561-19

EU CT Number:

Not Available
Study of BAY1834942 in patients with solid tumors

Trial purpose

This is an open-label, Phase 1, first-in-human, dose escalation and expansion study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and tumor response profile of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6) antibody BAY1834942 in patients with advanced solid tumors known to have a prevalence for CEACAM6 expression.
The study consists of dose escalation and a tumor type-specific expansion.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Male or female patients aged ≥ 18 years
    - Patients with histologically confirmed advanced/ metastatic solid tumors: Dose escalation: solid tumor types with a expression of CEACAM6 (gastric/ GEJ cancer, esophageal cancer, NSCLC, CRC, pancreatic cancer, cervical cancer, breast cancer, bladder cancer, head and neck squamous cell cancer, bile duct cancer); Dose expansion: advanced adeno NSCLC, CRC and gastric/ GEJ adenocarcinoma.
    - ECOG-PS of 0 to 1.
    - Adequate organ function (bone marrow, liver, kidneys).
    - Adequate coagulation function.
    - Adequate cardiac function

  • - Patients with active symptomatic or untreated brain metastases; possible exceptions for patients with treated asymptomatic central nervous system metastases
    - Active autoimmune disease
    - History or evidence of active pulmonary fibrosis, organizing pneumonia, or pneumonitis.
    - Risk factors for bowel obstruction or bowel perforation
    - History of cardiac disease
    - Uncontrolled arterial hypertension despite optimal medical management
    - Clinically relevant findings in electrocardiogram
    - HIV infection
    - Active HBV or HCV infection

Trial summary

Enrollment Goal
30
Trial Dates
June 2018 - February 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1834942
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Completed
Sarah Cannon Research InstituteNashville, 37203, United States
Completed
National University HospitalSingapore, 119074, Singapore
Completed
Princess Margaret Hospital-University Health NetworkToronto, M5G 2M9, Canada
Withdrawn
Mary Crowley Medical Research CenterDallas, 75230, United States
Withdrawn
Roswell Park Comprehensive Cancer CenterBuffalo, 14203, United States

Primary Outcome

  • Incidence of treatment-emergent adverse events
    date_rangeTime Frame:
    Up to 40 months
  • Severity of treatment-emergent adverse events
    Using the Common Terminology Criteria for Adverse Events (CTCAE) scale
    date_rangeTime Frame:
    Up to 40 months
  • Cmax of BAY1834942 after single dose
    Maximum plasma concentration of drug after single dose
    date_rangeTime Frame:
    0 (pre-dose), 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 168, 336 and 504 h after drug in Cycle 1 (cycle length is 21 days)
  • AUC(0-504) of BAY1834942 after single dose
    Area under the plasma concentration curve of drug from 0 to 504 hours after single dose
    date_rangeTime Frame:
    0 (pre-dose), 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 168, 336 and 504 h after drug in Cycle 1 (cycle length is 21 days)

Secondary Outcome

  • AUC(0-504),md of BAY1834942 after multiple doses
    Area under the plasma concentration curve of drug from 0 to 504 hours after multiples doses.
    date_rangeTime Frame:
    0 (pre-dose), 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 168, 336 and 504 h in Cycle 3 (cycle length is 21 days)
  • Cmax,md of BAY1834942 after multiple doses
    Maximum plasma concentration of drug after multiples doses
    date_rangeTime Frame:
    0 (pre-dose), 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 168, 336 and 504 h in Cycle 3 (cycle length is 21 days)
  • Overall response rate (ORR)
    Percentage of patients whose best response to BAY1834942 is either a Complete response or Partial response, both defined according to RECIST criteria
    date_rangeTime Frame:
    Up to 40 months
  • Leukocyte immune phenotyping
    Whole blood flow cytometry (FACS) for characterization of blood leukocytes/ lymphocytes with regard to subpopulations, differentiation and activation before and under treatment in all patients
    date_rangeTime Frame:
    Screening; 0 (pre-dose), 24, 168, 336 h after drug on Day 1 of Cycle 1 (cycle length is 21 days); 0 (pre-dose), 24, 168 h after drug on Day 1 of Cycle 2; 0 (pre-dose), 24 h after drug on Day 1 of Cycle 3; 0 h (pre-dose) on Day 1 of Cycles 4, 6 and 8
  • CEACAM6 receptor occupancy
    Total and free CEACAM6 expression levels on blood granulocytes and monocytes as assessed by whole blood flow cytometry (FACS) using 2 different fluorescence-labeled anti-CEACAM6 antibodies either competing or not in CEACAM6 binding with BAY1834942 determined before and under treatment in all dose escalation cohorts
    date_rangeTime Frame:
    0 (pre-dose), 24, 168 and 336 h after drug on Day 1 of Cycle 1 (cycle length is 21 days); 0 h (pre-dose) on Day 1 of Cycle 2
  • Cytokine levels
    Total concentration of proinflammatory and immunostimulatory cytokines and of soluble interleukin 2 receptor in serum derived from whole blood taken before and under treatment in all patients
    date_rangeTime Frame:
    Screen.; 0 (pre-dose), 4, 24, 168, 336 h after drug on Day 1 of Cycle 1 (cycle length 21 days); 0 (pre-dose), 4, 24, 168 h after drug on Day 1 of Cycle 2; 0 (pre-dose), 4, 24 h after drug on Day 1 of Cycle 3; 0 h (pre-dose) on Day 1 of Cycles 4, 6 and 8
  • Ex vivo-stimulated cytokine secretion
    Total concentration of selected proinflammatory and immunostimulatory cytokines in culture plasma after 24 hour ex-vivo stimulation of whole blood taken before and under treatment in all patients
    date_rangeTime Frame:
    0 h (pre-dose) on Day 1 of Cycles 1, 2, 3, 4, 6 and 8 (cycle length is 21 days)
  • Concentration of carcinoembryonic antigens (CEA; tumor marker) in serum
    Total concentration of CEA in serum derived from whole blood taken before and under treatment in all patients
    date_rangeTime Frame:
    0 h (pre-dose) on Day 1 of Cycles 1, 2, 3, 4, 6 and 8 (cycle length is 21 days)
  • Concentration of anti-drug antibodies
    Concentration in plasma
    date_rangeTime Frame:
    Day 1 (pre-dose) of Cycles 1, 2, 3, 4, 6 and subsequent odd-numbered cycles (cycle length is 21 days); 1 Day of End of treatment; 1 Day of Safety Follow-up visit

Trial design

An open-label, Phase 1, first-in-human, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and tumor response profile of the anti-CEACAM6 antibody BAY1834942 in patients with advanced solid tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
5

Additional Information

Click here to find results for studies related to Bayer products