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Berzosertib

Phase 1

Advanced Stage Solid Tumors | Small molecule | Oncology |Merck KGaA|Last Updated: Nov 29, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment1

FDA Designations

No designations recorded

Clinical trial landscape

Berzosertib · 1 trial · 1 indication

Phase 1 1
NCT03309150ATRi Transition Rollover StudyAdvanced Stage Solid Tumors
COMPLETED1 Analytics
PHASE1COMPLETED
ATRi Transition Rollover Study
Advanced Stage Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events (AEs) and Treatment Related AEs
Up to 6 years

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-related AEs: reasonably related to the study intervention.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A1: BerzosertibEXPERIMENTAL -

Interventions

NameTypeDescription
BerzosertibDRUGParticipants received intravenous infusion of Berzosertib at a dose of 126 milligrams (mg) on Days 1, 8 and 15 until disease progression or unacceptable toxicity occurred.
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participants ongoing treatment in Vertex study VX13-970-002. * Participant must be able to understand and provide written informed consent. * Participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive gu...

Countries:United Kingdom
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Frequently asked questions about Berzosertib

What is Berzosertib used for?

Berzosertib is an investigational small molecule being studied for the treatment of advanced stage solid tumors. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Berzosertib?

Berzosertib is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical trials for advanced stage solid tumors.

What phase is Berzosertib in?

Berzosertib is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is Berzosertib in?

Berzosertib has one completed Phase 1 trial, identified as NCT03309150, titled 'ATRi Transition Rollover Study'. This trial enrolled one participant with advanced stage solid tumors in the United Kingdom.

Is Berzosertib FDA approved?

Berzosertib is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced stage solid tumors, and its safety and efficacy have not been established.