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BAY2010112

Phase 1

Prostatic Neoplasms | Monoclonal antibody | Oncology |Bayer AG|Last Updated: Sep 27, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

BAY2010112 · 1 trial · 1 indication

Phase 1 1
NCT01723475First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate CancerProstatic Neoplasms
COMPLETED47 Analytics
PHASE1COMPLETED
First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer
Prostatic Neoplasms
NCT0172347547
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Study Endpoints

Primary Endpoints

Number of participants with Adverse Events as a Measure of Safety and Tolerability
Up to 2 years or longer if indicated
Maximum Tolerated Dose (MTD)
Up to 2 years or longer if indicated

MTD is measured by adverse event profile at the end of Cycle 1. MTD will be the highest dose level achieved during dose escalation where the incidence of dose-limiting toxicities (DLTs) is below 20%

Secondary Endpoints

Maximum drug concentration (Cmax) of BAY2010112 in serum after single and multiple doses administration
Cycle 1 Day1 and 15; (1 Cycle is 21 days long)
Area under the concentration versus time curve (AUC) from zero to infinity after single (first) and multiple doses of BAY2010112
Cycle 1 (1 Cycle is 21 days long)
Tumor response
Up to 2 years or longer if indicated
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY2010112 (s.c.)EXPERIMENTAL -
BAY2010112 (c.i.v.)EXPERIMENTAL -

Interventions

NameTypeDescription
BAY2010112BIOLOGICALSubcutaneous (s.c.) administration once daily. Starting dose will be 0.5 µg ; dose will be escalated dependent on any dose limiting toxicities
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Male subjects, aged \>/= 18 years * Subjects with histologically or cytologically proven advanced castration-resistant prostate cancer (CRPC) * who failed at least 1 taxane regimen and are refractory to abiraterone and/or enzalutamide therapy OR * who have actively refuse...

Countries:AustriaGermany
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Frequently asked questions about BAY2010112

What is BAY2010112 used for?

BAY2010112 is an investigational monoclonal antibody being studied for the treatment of prostate cancer, specifically prostatic neoplasms. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does BAY2010112 target?

BAY2010112 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its potential to treat prostate cancer, though the exact mechanism of action remains under investigation.

Who makes BAY2010112?

BAY2010112 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with prostate cancer.

What phase is BAY2010112 in?

BAY2010112 is in Phase 1 clinical development. A first-in-human dose escalation study has been completed, involving 47 patients with prostate cancer. The drug remains investigational and has not received FDA approval.

What clinical trials is BAY2010112 in?

BAY2010112 has been studied in one completed Phase 1 clinical trial, NCT01723475, titled 'First-in-man Dose Escalation Study of BAY2010112 in Patients With Prostate Cancer.' The trial enrolled 47 male patients aged 18 years and older in Austria and Germany.

Is BAY2010112 the same as any other drug?

No alternative names for BAY2010112 have been reported in clinical trial records. The drug is identified solely by its code name BAY2010112 in the context of its development by Bayer AG for prostate cancer.