Trial Condition(s):
Advanced CEACAM6-expressing solid tumors
Study of BAY1834942 in patients with solid tumors
Bayer Identifier:
18650
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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 functionExclusion Criteria
- 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 infectionTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sarah Cannon Research Institute Nashville, United States, 37203 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National University Hospital Singapore, Singapore, 119074 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Princess Margaret Hospital-University Health Network Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Incidence of treatment-emergent adverse eventsTimeframe: Up to 40 months
- Severity of treatment-emergent adverse eventsUsing the Common Terminology Criteria for Adverse Events (CTCAE) scaleTimeframe: Up to 40 months
- Cmax of BAY1834942 after single doseMaximum plasma concentration of drug after single doseTimeframe: 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 doseArea under the plasma concentration curve of drug from 0 to 504 hours after single doseTimeframe: 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 dosesArea under the plasma concentration curve of drug from 0 to 504 hours after multiples doses.Timeframe: 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 dosesMaximum plasma concentration of drug after multiples dosesTimeframe: 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 criteriaTimeframe: Up to 40 months
- Leukocyte immune phenotypingWhole blood flow cytometry (FACS) for characterization of blood leukocytes/ lymphocytes with regard to subpopulations, differentiation and activation before and under treatment in all patientsTimeframe: 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 occupancyTotal 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 cohortsTimeframe: 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 levelsTotal 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 patientsTimeframe: 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 secretionTotal 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 patientsTimeframe: 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 serumTotal concentration of CEA in serum derived from whole blood taken before and under treatment in all patientsTimeframe: 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 antibodiesConcentration in plasmaTimeframe: 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
Additional Information
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