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PARP inhibitor 2X-121

Phase 2

Metastatic Breast Cancer | Small molecule | Oncology |Allarity Therapeutics, Inc.|Last Updated: Jan 23, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03562832Investigation of Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRPPHASE2 COMPLETED 20Jun 20, 2018Aug 1, 2024Jan 23, 20252 Denmark
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Study Endpoints
Primary Endpoints
Anti-tumour efficacy after treatment with 600 mg 2X-121 as single oral agent in a 21-days cycle in mBC patients selected by the 2X-121 DRP
one year

Overall tumor response according to RECIST

Secondary Endpoints
Progression free survival (PFS) after administration of 2X-121 in patients with mBC
one year
Duration of objective response after administration of 2X-121 in patients with mBC
one year
Overall survival (OS) after administration of 2X-121 in patients with mBC
one year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PARP inhibitor 2X-121EXPERIMENTAL600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients
Interventions
NameTypeDescription
PARP inhibitor 2X-121DRUG600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Signed informed consent form. * Age 18 years or older. * Histologically or cytological documented mBC (independent of hormone receptor, HER2 status and BRCA1 or 2 status) relapsed in 2 or more different prior therapies. * Measurable disease by CT scan or MRI. * With a drug res...

Countries:Denmark
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Competitive Landscape -Breast Cancer 408 trials
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