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BAY2416964

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bayer AG|Last Updated: Mar 6, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

BAY2416964 · 1 trial · 1 indication

Phase 1 1
NCT04069026A First-in-Humans Dose Finding Study for an Aryl Hydrocarbon Receptor Inhibitor (AhRi) in Patients With Advanced CancerAdvanced Solid Tumors
COMPLETED78 Analytics
PHASE1COMPLETED
A First-in-Humans Dose Finding Study for an Aryl Hydrocarbon Receptor Inhibitor (AhRi) in Patients With Advanced Cancer
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

The incidence of treatment emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs) and dose-limiting toxicities (DLTs)
Up to 90 days after end of treatment
Severity of treatment emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs) and dose-limiting toxicities (DLTs)
Up to 90 days after end of treatment
Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964
Cycle 1 (21 days) in dose escalation

MTD:defined as the dose level that can be given such that the estimated Dose limiting toxicity (DLT) probability is closest to approximately 25%.

Recommended Phase II dose (RP2D) of BAY2416964
Up to 90 days after end of treatment

Integration of all available safety, PK and PD data

Maximal plasma exposure (Cmax) for once daily (QD) dosing of BAY2416964 after single-dose and multiple-dose in Cycle 1.
From pre-dose up to 24 hours after administration on Cycle 1 (21 days) Day 1. From pre-dose up to 12 hours after administration on Cycle 1 (21 days) Day 15
Area under the curve [AUC (0 - t)] (t=6,12 or 24 dependent on the dosing regimen) of BAY2416964 after single and multiple-dose in Cycle 1
From pre-dose up to 6, 12, or 24 hours after administration on Day 1 and/or Day 15 in Cycle 1 (21 days).

Secondary Endpoints

Objective response rate (ORR) by RECIST 1.1
At the end of Cycle 2 (- 7 days), Cycle 4 (-7 days), every 9 weeks (- 7 days) from Cycle 5 to Cycle 10 and every 4th cycle (- 7 days) from Cycle 11 onwards. Each cycle is 21 days.
Change from baseline in AhR target gene expression in whole blood after ex-vivo stimulation
Screening, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 4 Day 1(each cycle is 21 days)
Cytokine measurements, e.g. IL-6 (immunoassay), in whole blood after ex-vivo stimulation.
Screening, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 4 Day 1(each cycle is 21 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose escalation of BAY2416964EXPERIMENTALApproximately 8 dose levels of BAY2416964 are planned
Dose expansion of BAY2416964 in tumor type specificEXPERIMENTALPatients with NSCLC, HNSCC

Interventions

NameTypeDescription
BAY2416964DRUGOral application of study drug daily in a predefined dose escalation scheme.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Participants must be ≥18 years of age inclusive, at the time of signing the informed consent. * Participants with following histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease ...

Countries:United StatesCanadaGermanySpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about BAY2416964

What is BAY2416964 used for?

BAY2416964 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, and a first-in-human trial has been completed to evaluate its safety and tolerability in patients with advanced cancer.

What does BAY2416964 target?

BAY2416964 is an aryl hydrocarbon receptor (AhR) inhibitor. It works by blocking the activity of the aryl hydrocarbon receptor, which is involved in tumor progression and immune suppression. This mechanism is being explored as a potential therapeutic approach for advanced solid tumors.

Who makes BAY2416964?

BAY2416964 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 BAY2416964 in?

BAY2416964 is in Phase 1 clinical development. A first-in-human dose-finding study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation for advanced solid tumors.

What clinical trials is BAY2416964 in?

BAY2416964 has been studied in one completed Phase 1 clinical trial, identified as NCT04069026. This trial was a first-in-human dose-finding study that enrolled 78 patients with advanced solid tumors across the United States, Canada, Germany, Spain, and the United Kingdom.

Is BAY2416964 the same as an AhR inhibitor?

BAY2416964 is an aryl hydrocarbon receptor (AhR) inhibitor, and it is sometimes referred to as an AhRi in clinical trial documentation. It is a small molecule designed to inhibit the aryl hydrocarbon receptor, and it is being investigated for the treatment of advanced solid tumors.