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XmAb541

Phase 1

Ovarian Cancer | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: Aug 25, 2026

Target and mechanism

Molecular targetCLDN6
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment372

FDA Designations

No designations recorded

Clinical trial landscape

XmAb541 · 2 trials · 5 indications

Phase 1 2
NCT07593092Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid TumorsOvarian Cancer
RECRUITING90 Analytics
NCT06276491Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid TumorsOvarian Cancer
RECRUITING282 Analytics
PHASE1RECRUITING
Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors
Ovarian CancerUnlock trial analytics
PHASE1RECRUITING
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Ovarian CancerUnlock trial analytics

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 to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites4

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 StatesBelgiumDenmarkSpain
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
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
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT06276491lastUpdatePostDate: changed
LOWAug 25, 2026NCT06276491lastUpdatePostDate: changed
LOWAug 14, 2026NCT07593092Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 14, 2026NCT07593092Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 14, 2026NCT07593092Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 11, 2026NCT06276491lastUpdatePostDate: changed
LOWJun 11, 2026NCT06276491lastUpdatePostDate: changed

Frequently asked questions about XmAb541

What is XmAb541 used for in ovarian cancer?

XmAb541 is an investigational monoclonal antibody being developed for ovarian cancer. It is currently in Phase 1 clinical trials studying its safety and tolerability in advanced solid tumors, including ovarian cancer. The drug is not yet approved and remains in clinical development.

What does XmAb541 target?

XmAb541 targets CLDN6, a protein found on the surface of certain tumor cells. By binding to CLDN6, the antibody is designed to direct an immune response against cancer cells expressing this protein. This mechanism is being evaluated in early-stage clinical trials for ovarian cancer.

Who makes XmAb541?

XmAb541 is being developed by Xencor, Inc., a biopharmaceutical company traded on NASDAQ under the ticker XNCR. Xencor is conducting Phase 1 clinical trials to evaluate the safety and tolerability of XmAb541 in patients with advanced solid tumors.

What phase is XmAb541 in?

XmAb541 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials are currently recruiting patients to assess the safety, tolerability, and preliminary activity of XmAb541 in advanced solid tumors.

What clinical trials is XmAb541 in?

XmAb541 is being studied in two Phase 1 trials. NCT06276491 evaluates XmAb541 alone in advanced solid tumors, including ovarian, endometrial, and germ cell tumors, with an enrollment of 282. NCT07593092 studies XmAb541 in combination with XmAb808 in ovarian cancer, enrolling 90 patients.

Is XmAb541 the same as XmAb808?

No, XmAb541 and XmAb808 are different investigational drugs. XmAb541 targets CLDN6 and is being studied alone or in combination with XmAb808. A Phase 1 trial, NCT07593092, is evaluating the combination of XmAb541 and XmAb808 in patients with ovarian cancer.