Recent Updates
Recently added Catalysts

BAY2862789

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bayer AG|Last Updated: Aug 11, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

BAY2862789 · 1 trial · 2 indications

Phase 1 1
NCT05858164A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Participants With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED45 Analytics
PHASE1COMPLETED
A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Participants With Advanced Solid Tumors
Advanced Solid Tumors
NCT0585816445
Unlock trial analytics

Study Endpoints

Primary Endpoints

The number and severity of treatment-emergent adverse events (TEAEs)
Up to 90 days after the last administration of the study treatment

Adverse events (AEs) will be considered treatment-emergent if they have started or worsened after first administration of study treatment up to 90 days after the last administration of study treatment.

Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level in the Dose Escalation part of the study
Up to 21 days after the first administration of the study treatment
Recommended Dose for Expansion (RDE)
Up to 2 years

RDE: as determined by safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) and efficacy data

Maximum concentration (Cmax) BAY2862789 after single-dose
from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Maximum concentration (Cmax) BAY2862789 after multiple-dose
Pre-dose and up to 24 hours after Day 16 in Cycle 1
Area under the curve (AUC) BAY2862789 after single-dose
from pre-dose up to 24 hours after administration on Cycle 1 Day 1 (each cycle is 21 days)
Area under the curve (AUC) BAY2862789 after multiple-dose
Pre-dose and up to 24 hours after Day 16 in Cycle 1

Secondary Endpoints

Objective response rate (ORR)
Up to 2 years
Disease control rate (DCR)
Up to 2 years
Duration of response (DOR)
Up to 2 years
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALParticipants will take BAY2862789 oral doses.

Interventions

NameTypeDescription
BAY2862789DRUGOral administration, solution or tablets
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Capable of giving signed informed consent * Be ≥18 years of age on day of signing informed consent. * Have measurable disease per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) as assessed by the local site investigator. * Have an Eastern Cooperative On...

Countries:United StatesAustraliaChinaIsraelSouth KoreaSpain
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
Unlock Competitive Intelligence

Frequently asked questions about BAY2862789

What is BAY2862789 used for?

BAY2862789 is an investigational small molecule being studied for the treatment of advanced solid tumors, including non-small cell lung cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing BAY2862789?

BAY2862789 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 BAY2862789 in?

BAY2862789 is in Phase 1 clinical development. A first-in-human study has been completed to evaluate its safety, tolerability, and pharmacokinetics in participants with advanced solid tumors.

What clinical trials is BAY2862789 in?

BAY2862789 has been studied in a Phase 1 clinical trial registered as NCT05858164. This first-in-human study enrolled 45 participants with advanced solid tumors, including non-small cell lung cancer, and was conducted in the United States, Australia, China, Israel, South Korea, and Spain.

Is BAY2862789 FDA approved?

BAY2862789 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, and it remains in clinical development for advanced solid tumors.