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2X-121

Phase 2

Advanced Ovarian Cancer | Small molecule | Oncology |Allarity Therapeutics, Inc.|Last Updated: Aug 28, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03878849Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian CancerPHASE2 RECRUITING 40Apr 15, 2019Sep 1, 2027Aug 28, 20252 United States
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Study Endpoints
Primary Endpoints
Evaluate the optimal dose of 2X-121 as single agent therapy
From enrollment up to approximately 2 years

To evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily compared to 800 mg daily.

Secondary Endpoints
Clinical benefit rate (CBR)
From enrollment up to approximately 2 years
Progression free survival
From enrollment up to approximately 2 years
Overall survival
From enrollment up to approximately 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Drug: 2X-121 600 mgEXPERIMENTAL2X-121 will be administered daily as 600 mg (200 mg 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.
Drug: 2X-121 800 mgEXPERIMENTAL2X-121 will be administered 800 mg (400 mg (2 x 200 mg) 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.
Interventions
NameTypeDescription
2X-121DRUG2X-121 will be administered daily as 600 mg (200 mg 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Signed informed consent form. 2. Age 18 years or older. 3. Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1...

Countries:United States
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Competitive Landscape -Ovarian Cancer 180 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel, Sacituzumab tirumotecan
AstraZeneca PLCAZN19PHASE3Olaparib, Bevacizumab, Durvalumab, Carboplatin+Paclitaxel, AZD5335
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab, Mirvetuximab soravtansine, Carboplatin, Mirvetuximab Soravtansine
GSK plc Sponsored ADRGSK4PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab, BMS-986340, BMS-936558-01, Docetaxel
Pfizer Inc.PFE5PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel /m^2, Relacorilant once daily, Bevacizumab /kg
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib, azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib, KFA115, pembrolizumab, Tulmimetostat
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib, BG-68501, Fulvestrant, BGB-43395
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib, cabozantinib, atezolizumab
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03878849primaryCompletionDate: changed
LOWMay 24, 2026NCT03878849studyFirstPostDate: changed