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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

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

PARP inhibitor 2X-121 · 1 trial · 1 indication

Phase 2 1
NCT03562832Investigation of Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRPMetastatic Breast Cancer
COMPLETED20 Analytics
PHASE2COMPLETED
Investigation of Anti-tumour Effect and Tolerability of the PARP Inhibitor 2X-121 in Patients With Metastatic Breast Cancer Selected by the 2X-121 DRP
Metastatic Breast CancerUnlock trial analytics

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 to 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 402 trials (matched to "Metastatic Breast Cancer")

Top 20 of 93 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2-endoxifen, goserelin
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Frequently asked questions about PARP inhibitor 2X-121

What is PARP inhibitor 2X-121 used for?

PARP inhibitor 2X-121 is an investigational small molecule being studied for the treatment of metastatic breast cancer. It is a PARP inhibitor, a class of drugs that targets poly (ADP-ribose) polymerase enzymes involved in DNA repair. The drug is currently in Phase 2 clinical development.

What does PARP inhibitor 2X-121 target?

PARP inhibitor 2X-121 targets poly (ADP-ribose) polymerase (PARP) enzymes, which play a role in DNA repair. By inhibiting these enzymes, the drug is designed to interfere with cancer cells' ability to repair DNA damage, potentially leading to cell death. It is being investigated for metastatic breast cancer.

Who makes PARP inhibitor 2X-121?

PARP inhibitor 2X-121 is being developed by Allarity Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ALLR. The company is conducting clinical research on this investigational drug for the treatment of metastatic breast cancer.

What phase is PARP inhibitor 2X-121 in?

PARP inhibitor 2X-121 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with metastatic breast cancer.

What clinical trials is PARP inhibitor 2X-121 in?

PARP inhibitor 2X-121 has one completed clinical trial, identified as NCT03562832. This Phase 2 study investigated the anti-tumour effect and tolerability of the drug in 20 patients with metastatic breast cancer in Denmark. The trial was uncontrolled, meaning there was no comparison group, and it enrolled adults aged 18 years and older.