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BAY2701439

Phase 1

Cancers With HER2 Expression | Small molecule | Oncology |Bayer AG|Last Updated: Sep 27, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

BAY2701439 · 1 trial · 1 indication

Phase 1 1
NCT04147819A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 ProteinCancers With HER2 Expression
COMPLETED14 Analytics
PHASE1COMPLETED
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein
Cancers With HER2 Expression
NCT0414781914
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Study Endpoints

Primary Endpoints

Dose escalation: Incidence of TEAEs including TESAEs
After first administration of study intervention up to 42 days after the last dose of study intervention

TEAE: Treatment-emergent adverse event TESAE: Treatment-emergent serious adverse event

Dose escalation: Severity of TEAEs including TESAEs
After first administration of study intervention up to 42 days after the last dose of study intervention
Dose escalation: Frequency of DLTs at each dose level
Up to 42 days after first administration of study intervention on cycle 1 (42 days) day 1

DLT:Dose limiting toxicity

Dose expansion: ORR by RECIST 1.1 based on Investigator review
Up to 12 months after End of treatment

ORR: Objective response rate

Dose expansion: Frequency of TEAEs
After first administration of study intervention up to 42 days after the last dose of study intervention
Dose expansion: Severity of TEAEs
After first administration of study intervention up to 42 days after the last dose of study intervention

Secondary Endpoints

Dose escalation: Recommended dose level(s) of BAY2701439 for the dose expansion cohorts
Maximum 6 cycles (each cycle is 42 days)
Dose escalation: Recommended treatment schedule of BAY2701439 for the dose expansion cohorts
Maximum 6 cycles (each cycle is 42 days)
Dose expansion: Recommended dose for further clinical development of BAY2701439
Maximum 6 cycles (each cycle is 42 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose escalation of BAY2701439EXPERIMENTALThe target population consists of participants with advanced HER2-expressing/amplified breast, gastric or gastroesophageal cancer.
HER2 overexpressing breast cancerEXPERIMENTALDose expansion of BAY2701439
HER2 low expressing breast cancerEXPERIMENTALDose expansion of BAY2701439
Other HER2 overexpressing advanced carcinomasEXPERIMENTALDose expansion of BAY2701439

Interventions

NameTypeDescription
BAY2701439DRUGIntravenous (IV) injection on Day 1 of each cycle.The duration of each cycle will be 6 weeks (42 days).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Male or female participants at least 18 years of age on the day of signing informed consent. * Participants must meet the study phase-specific disease requirements: Dose escalation: Pathologically documented, HER2-expressing (IHC3+, 2+, or 1+ and/or ISH+), unresectable local...

Countries:United StatesUnited Kingdom
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Frequently asked questions about BAY2701439

What is BAY2701439 used for?

BAY2701439 is an investigational small molecule being studied for the treatment of cancers with HER2 expression. It is intended for participants with advanced cancer that expresses the HER2 protein. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does BAY2701439 target?

BAY2701439 targets cancers that express the HER2 protein. It is designed to work in participants with advanced cancer expressing HER2, as indicated by the clinical trial inclusion criteria. The specific molecular mechanism of action has not been disclosed in the available information.

Who makes BAY2701439?

BAY2701439 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the over-the-counter market. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug.

What phase is BAY2701439 in?

BAY2701439 is in Phase 1 clinical development. A first-in-human study has been completed to evaluate its safety, how the body absorbs, distributes and excretes the drug, and how well it works in participants with advanced cancer expressing the HER2 protein. The drug remains investigational.

What clinical trials is BAY2701439 in?

BAY2701439 has one completed clinical trial, NCT04147819, a first-in-human study conducted in the United States and United Kingdom. The study enrolled 14 participants with cancers expressing HER2 and was a controlled, open-label trial. No active trials are currently listed for this drug.

Is BAY2701439 the same as any other drug?

No alternative names for BAY2701439 have been disclosed in the available information. The drug is identified solely by its code name BAY2701439 in clinical trial records and development documentation. It is not known to be marketed under any other brand name.