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ZW25

Phase 2

Endometrial Cancer | Small molecule | Oncology |Zymeworks Inc.|Last Updated: May 22, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04513665ZW25 in Women With Endometrial CancersPHASE2 COMPLETED 16Aug 12, 2020Mar 8, 2024May 22, 20257 United States
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Study Endpoints
Primary Endpoints
Overall Response Rate/ORR of Participants
</= 24 weeks from the start of treatment

ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1EXPERIMENTALParticipants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants.
Stage 2EXPERIMENTALIf 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy.
Interventions
NameTypeDescription
ZW25DRUGZW25 at 20mg/kg intravenously (IV) every two weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Patients must be enrolled or agree to consent to the companion genomic profiling study MSKCC IRB# 12-245 Part A. Results are not required prior to initiating treatment on protocol, unless patients do not have other test results by IHC or FISH confirming HER2 overexpression. * ...

Countries:United States
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Competitive Landscape -Endometrial Cancer 113 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Sacituzumab tirumotecan, Doxorubicin, Paclitaxel, Nab-paclitaxel, Pembrolizumab
AstraZeneca PLCAZN14PHASE3olaparib, durvalumab, Carboplatin, Paclitaxel, Durvalumab + Chemotherapy phase
Gilead Sciences, Inc.GILD2PHASE3Sacituzumab govitecan-hziy, Doxorubicin, Paclitaxel
GSK plc Sponsored ADRGSK3PHASE3Mocertatug rezetecan, Paclitaxel, Doxorubicin, Dostarlimab, Carboplatin
BioNTech SE Sponsored ADRBNTX1PHASE3BNT323/DB-1303, Doxorubicin, Paclitaxel, Docetaxel
Genmab A/S Sponsored ADRGMAB3PHASE3Rina-S, IC, GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells., Carboplatin, Bevacizumab
Karyopharm Therapeutics, Inc.KPTI1PHASE3Selinexor
Pfizer Inc.PFE4PHASE2tucatinib, trastuzumab, fulvestrant, disitamab vedotin, PF-08052666
HUTCHMED (China) Limited Sponsored ADRHCM1PHASE3fruquintinib, sintilimab, paclitaxel, doxorubicin
Eli Lilly and CompanyLLY5PHASE1LY3537982, Pembrolizumab, Cetuximab, Pemetrexed, Cisplatin
Incyte CorporationINCY1PHASE2retifanlimab, epacadostat, pemigatinib, INCAGN02385, INCAGN02390
Jazz Pharmaceuticals Public Limited CompanyJAZZ2PHASE2Zanidatamab
Corcept Therapeutics Incorporated.CORT1PHASE2Relacorilant once daily, Nab-paclitaxel /m^2, Bevacizumab /kg
Xencor, Inc.XNCR2PHASE2vudalimab, XmAb541
Acrivon Therapeutics, Inc.ACRV1PHASE2ACR-368, Gemcitabine
MacroGenics, Inc.MGNX2PHASE2Lorigerlimab, MGC026 Dose Escalation
Iovance Biotherapeutics IncIOVA1PHASE2Lifileucel
Regeneron Pharmaceuticals, Inc.REGN2PHASE1REGN5668, Cemiplimab, Ubamatamab, Sarilumab, Tocilizumab
IDEAYA Biosciences, Inc.IDYA2PHASE1IDE-161, Pembrolizumab, IDE034
Bristol-Myers Squibb CompanyBMY1PHASE1BMS-986463
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