Advanced CEACAM6-expressing Solid TumorsPhase 1NCT03596372

Study of BAY1834942 in Patients With Solid Tumors

A Phase 1 study testing BAY1834942 in people with Advanced CEACAM6-expressing Solid Tumors, run by Bayer at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced CEACAM6-expressing Solid Tumors
What is being tested?: BAY1834942
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 4 sitesin 3 countries
Study dates: 19 Jun 2018to 22 Feb 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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Clinically relevant findings in electrocardiogram
HIV infection
Active HBV or HCV infection

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

United States2 sites

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203

Other trials in United States

Canada1 site

Princess Margaret Hospital-University Health Network
Toronto, Ontario, M5G 2M9

Other trials in Canada

Singapore1 site

National University Hospital
Singapore, 119074

Other trials in Singapore

About this study

Official title: 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

The study consists of dose escalation and a tumor type-specific expansion.

Read the detailed description

The primary objectives of the study are to evaluate and characterize the tolerability and safety profile of repeated doses of BAY1834942, and to characterize the pharmacokinetics of BAY1834942 after single dose.

Secondary objectives are to evaluate the tumor response profile, pharmacodynamics, pharmacokinetics and immunogenicity after multiple doses of the drug.

Conditions: Advanced CEACAM6-expressing Solid Tumors
Being tested: BAY1834942
Keywords: First-in-human, Immuno-oncology, CEACAM6, Checkpoint inhibition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BAY1834942Drug
Also called Anti-CEACAM6 antibody
Dose escalation:
Sequential dose levels
.
Dose expansion (except for low-dose expansion):
With maximum tolerated dose (MTD) identified in dose escalation part.

Study groups in NCT03596372
Study group	Role	What they receive
Patients with Solid tumors	Experimental	Dose escalation with patients having solid tumors. Patients receive escalating doses of BAY1834942 intravenously for 1 hour on Day 1 of each 21-day cycle (Q3W). If the Q3W scheme does not result in sufficient exposure, the scheme is replaced with an once-weekly (QW) dosing scheme. Receives: Drug: BAY1834942
Patients with Gastric cancer	Experimental	Expansion with patients having gastric and/or gastroesophageal adenocarcinoma: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part. Receives: Drug: BAY1834942
Patients with Colorectal cancer	Experimental	Expansion with patients having colorectal cancer: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part. Receives: Drug: BAY1834942
Patients with Non-small-cell-lung cancer	Experimental	Expansion with patients having adeno Non-small-cell-lung cancer: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part. Receives: Drug: BAY1834942
Low-dose expansion	Experimental	Expansion with patients having the same cancer type (gastric cancer, or colorectal cancer, or non-small-cell lung cancer) and receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part with a dose lower than the maximum tolerated dose (MTD). Receives: Drug: BAY1834942

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of treatment-emergent adverse events
Measured: Up to 40 months
Severity of treatment-emergent adverse events
Using the Common Terminology Criteria for Adverse Events (CTCAE) scale
Measured: Up to 40 months
Cmax of BAY1834942 after single dose
Maximum plasma concentration of drug after single dose
Measured: 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
Measured: 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 outcomes (9)

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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 201822 Feb 2021

First posted23 Jul 2018
Study start19 Jun 2018
Primary completion16 Nov 2020
Study completion22 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced CEACAM6-expressing Solid TumorsStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03596372
Sponsor's protocol ID: 18650
Other IDs: 2018-002561-19, 2018
Status last verified: May 2022
First submitted: 26 Jun 2018
Last updated: 2 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Siu LL, Hong DS, Docke WD, Tetzner R, Trautwein M, Phelps C, Willuda J, Yu XQ, Nogai H, Johnson M, Goh BC. A Phase I Study of the Anti-CEACAM6 Antibody Tinurilimab (BAY 1834942) in Patients with Advanced Solid Tumors. Target Oncol. 2025 Jul;20(4):637-649. doi: 10.1007/s11523-025-01154-4. Epub 2025 Jun 4.
PubMed 40465170

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03596372
Acronym / sponsor ID: 18650
Conditions: Advanced CEACAM6-expressing Solid Tumors
Keywords: First-in-human, Immuno-oncology, CEACAM6, Checkpoint inhibition
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 19 Jun 2018 (actual)
Primary completion: 16 Nov 2020 (actual)
Study completion: 22 Feb 2021 (actual)
First posted: 23 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study consists of dose escalation and a tumor type-specific expansion.

Detailed description

Secondary objectives are to evaluate the tumor response profile, pharmacodynamics, pharmacokinetics and immunogenicity after multiple doses of the drug.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Patients with Solid tumors	Experimental	Drug: BAY1834942Dose escalation with patients having solid tumors. Patients receive escalating doses of BAY1834942 intravenously for 1 hour on Day 1 of each 21-day cycle (Q3W). If the Q3W scheme does not result in sufficient exposure, the scheme is replaced with an once-weekly (QW) dosing scheme.
Patients with Gastric cancer	Experimental	Drug: BAY1834942Expansion with patients having gastric and/or gastroesophageal adenocarcinoma: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part.
Patients with Colorectal cancer	Experimental	Drug: BAY1834942Expansion with patients having colorectal cancer: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part.
Patients with Non-small-cell-lung cancer	Experimental	Drug: BAY1834942Expansion with patients having adeno Non-small-cell-lung cancer: Patients receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part.
Low-dose expansion	Experimental	Drug: BAY1834942Expansion with patients having the same cancer type (gastric cancer, or colorectal cancer, or non-small-cell lung cancer) and receive BAY1834942 intravenously for 1 hour according to dosing scheme decided in escalation part with a dose lower than the maximum tolerated dose (MTD).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BAY1834942Also: Anti-CEACAM6 antibodyDose escalation: Sequential dose levels . Dose expansion (except for low-dose expansion): With maximum tolerated dose (MTD) identified in dose escalation part.	Drug	Low-dose expansion, Patients with Colorectal cancer, Patients with Gastric cancer, Patients with Non-small-cell-lung cancer, Patients with Solid tumors

Primary outcome

Incidence of treatment-emergent adverse events
Time frame: Up to 40 months
Severity of treatment-emergent adverse events
Time frame: Up to 40 months
Using the Common Terminology Criteria for Adverse Events (CTCAE) scale
Cmax of BAY1834942 after single dose
Time 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)
Maximum plasma concentration of drug after single dose
AUC(0-504) of BAY1834942 after single dose
Time 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)
Area under the plasma concentration curve of drug from 0 to 504 hours after single dose

9 secondary outcomes

AUC(0-504),md of BAY1834942 after multiple doses
Time 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
Time 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)
Time frame: Up to 40 months
Leukocyte immune phenotyping
Time 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
Time 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
Time 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
Time 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
Time 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
Time 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
Derived from this study: PubMed 40465170Siu LL, Hong DS, Docke WD, Tetzner R, Trautwein M, Phelps C, Willuda J, Yu XQ, Nogai H, Johnson M, Goh BC. A Phase I Study of the Anti-CEACAM6 Antibody Tinurilimab (BAY 1834942) in Patients with Advanced Solid Tumors. Target Oncol. 2025 Jul;20(4):637-649. doi: 10.1007/s11523-025-01154-4. Epub 2025 Jun 4.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bayer Study Director study director

Bayer

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1834942 in people with Advanced CEACAM6-expressing Solid Tumors, run by Bayer at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: Up to 40 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03596372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.