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BAY1834942

Phase 1

Advanced CEACAM6-expressing Solid Tumors | Small molecule | Oncology |Bayer AG|Last Updated: Jun 2, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

BAY1834942 · 1 trial · 1 indication

Phase 1 1
NCT03596372Study of BAY1834942 in Patients With Solid TumorsAdvanced CEACAM6-expressing Solid Tumors
COMPLETED30 Analytics
PHASE1COMPLETED
Study of BAY1834942 in Patients With Solid Tumors
Advanced CEACAM6-expressing Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
Up to 40 months
Severity of treatment-emergent adverse events
Up to 40 months

Using the Common Terminology Criteria for Adverse Events (CTCAE) scale

Cmax of BAY1834942 after single dose
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
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

Secondary Endpoints

AUC(0-504),md of BAY1834942 after multiple doses
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
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)
Up to 40 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Patients with Solid tumorsEXPERIMENTALDose 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 cancerEXPERIMENTALExpansion 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 cancerEXPERIMENTALExpansion 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 cancerEXPERIMENTALExpansion 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 expansionEXPERIMENTALExpansion 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).

Interventions

NameTypeDescription
BAY1834942DRUGDose escalation: Sequential dose levels . Dose expansion (except for low-dose expansion): With maximum tolerated dose (MTD) identified in dose escalation part.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 c...

Countries:United StatesCanadaSingapore
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Frequently asked questions about BAY1834942

What is BAY1834942 used for?

BAY1834942 is an investigational small molecule being developed for the treatment of advanced CEACAM6-expressing solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

How does BAY1834942 work?

BAY1834942 is a small molecule designed to target CEACAM6, a protein expressed on the surface of certain solid tumors. By interacting with CEACAM6, the drug aims to interfere with tumor cell processes, though the exact mechanism is not fully detailed in available information.

Who is developing BAY1834942?

BAY1834942 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.

What phase is BAY1834942 in?

BAY1834942 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.

What clinical trials is BAY1834942 in?

BAY1834942 has one completed Phase 1 trial, NCT03596372, titled 'Study of BAY1834942 in Patients With Solid Tumors.' The trial enrolled 30 participants with advanced CEACAM6-expressing solid tumors and was conducted in the United States, Canada, and Singapore.

Is BAY1834942 the same as any other drug?

No alternative names for BAY1834942 have been identified. It is a distinct investigational compound developed by Bayer AG.