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Atu027

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Silence Therapeutics Plc American Depository Share|Last Updated: Apr 9, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

Atu027 · 1 trial · 1 indication

Phase 1 1
NCT00938574Study With Atu027 in Patients With Advanced Solid CancerAdvanced Solid Tumors
COMPLETED34 Analytics
PHASE1COMPLETED
Study With Atu027 in Patients With Advanced Solid Cancer
Advanced Solid Tumors
NCT0093857434
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Study Endpoints

Primary Endpoints

Determination of dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of single and repeated intravenous infusion with Atu027 in subjects with advanced solid tumors
treatment and follow up

Secondary Endpoints

Collection of data concerning pharmacokinetics of Atu027 and its components
treatment and follow up
Collection of data concerning clinical safety and tolerability
treatment and follow up
Clinical response as measured by RECIST criteria
treatment and follow up
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Drug Atu027EXPERIMENTAL -

Interventions

NameTypeDescription
Atu027DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically and/or cytologically proven advanced, recurrent or metastatic solid malignancy for which standard curative or palliative measures do not exist, are no longer effective, or are unlikely to be effective. 2. Age \>/= 18 years. 3. ECOG performance score of 0-2. 4. ...

Countries:Germany
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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
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Frequently asked questions about Atu027

What is Atu027 used for?

Atu027 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is in Phase 1 clinical development and has not been approved by regulatory authorities. A single Phase 1 trial has been completed to evaluate its safety and tolerability in patients with advanced solid cancer.

Who is developing Atu027?

Atu027 is being developed by Silence Therapeutics Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol SLN. The company is conducting clinical research to evaluate the drug's potential in oncology, specifically for advanced solid tumors.

What phase is Atu027 in?

Atu027 is in Phase 1 clinical development. The drug is investigational and has not received regulatory approval. A Phase 1 study has been completed, but the drug remains in early-stage clinical testing and is not yet available as a treatment.

What clinical trials is Atu027 in?

Atu027 has been studied in one clinical trial, identified as NCT00938574, titled 'Study With Atu027 in Patients With Advanced Solid Cancer.' This Phase 1 trial was completed and enrolled 34 participants with advanced solid tumors in Germany. The study was uncontrolled and not randomized or double-blinded.

Is Atu027 FDA approved?

Atu027 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid tumors. The drug has completed a Phase 1 trial, but it has not been evaluated in later-stage trials or submitted for regulatory approval.