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XmAb541

Phase 1

Ovarian Cancer | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: May 18, 2026

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 Trials2
Total Enrollment372
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07593092Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid TumorsPHASE1 NOT YET_RECRUITING 90Jun 1, 2026Dec 1, 2028May 18, 20269 United States
NCT06276491Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid TumorsPHASE1 RECRUITING 282Apr 4, 2024Dec 1, 2028Mar 17, 202616 United States
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events
Day 1 to 2 years
Incidence of dose-limiting toxicities
Day 1 to Day 43
Incidence of dose-limiting toxicities (DLTs)
Day 1 to Day 28
Incidence of cytokine release syndrome (CRS)
Day 1 to Day 28
Secondary Endpoints
Measurement of Cmax
Day 1 - 2 years
Measurement of area under curve (AUC)
Day 1 to 2 years
Measurement of Ctrough
Day 1 to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation and Dose Expansion of XmAb541 and XmAb808EXPERIMENTAL -
Dose escalation and Dose Expansion of XmAb541EXPERIMENTALIntravenous or Subcutaneous administration
Interventions
NameTypeDescription
XmAb541BIOLOGICALMonoclonal Bispecific Antibody
XmAb808BIOLOGICALMonoclonal Bispecific Antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Age ≥ 18 years. * CLDN6+ tumor * Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin * Adequate Eastern Cooperative Oncology Group performance ...

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, 2026NCT06276491primaryCompletionDate: changed
LOWMay 26, 2026NCT07593092primaryCompletionDate: changed
LOWMay 24, 2026NCT06276491studyFirstPostDate: changed
LOWMay 24, 2026NCT07593092studyFirstPostDate: changed
LOWMay 21, 2026NCT07593092NEW_TRIAL: changed
LOWMay 21, 2026NCT07593092NEW_TRIAL: changed