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WTX-124

Phase 1

Metastatic Solid Tumor | Small molecule | Oncology |Werewolf Therapeutics, Inc.|Last Updated: Feb 9, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05479812Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 150 — — May 20, 2022Jul 31, 2026Feb 9, 202614 United States
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
4 weeks
Incidence of treatment emergent adverse events in monotherapy and combination therapy
24 months
Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
24 months
Dose Expansion - Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
4 weeks
Dose Expansion - Incidence of treatment emergent adverse events in monotherapy and combination therapy
24 months
Dose Expansion - Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
24 months
Dose Expansion - Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
24 months
Secondary Endpoints
Plasma concentrations of WTX-124 and free IL-2
24 months
Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
24 months
Changes in circulating immune cell populations in response to monotherapy and combination therapy
24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
WTX-124 monotherapy dose escalationEXPERIMENTALWTX-124 monotherapy dose escalation
WTX-124 in combination with pembro dose escalationEXPERIMENTALWTX-124 in combination with pembrolizumab (pembro) dose escalation
Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC.EXPERIMENTALArm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC.
Arm B: WTX-124 monotherapy dose expansion. Advanced or metastatic cutaneous malignant melanoma.EXPERIMENTALArm B: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cutaneous malignant melanoma.
Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC.EXPERIMENTALArm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC.
Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC.EXPERIMENTALArm D: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic RCC.
Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma.EXPERIMENTALArm E: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic cutaneous melanoma.
Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCLEXPERIMENTALArm F: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic PD-L1-positive NSCLC lines.
Interventions
NameTypeDescription
WTX-124DRUGInvestigation Product Monotherapy
pembrolizumabDRUGInvestigation Product in combination with approved therapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: Each patient must meet all the following criteria to participate in the study: 1. Has histological or cytological documentation of a solid tumor indication for which a CPI (e.g. anti-PD-(L)1 is indicated for all parts of the clinical study; 2. Monotherapy Dose Escalation: P...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05479812primaryCompletionDate: changed
LOWMay 24, 2026NCT05479812studyFirstPostDate: changed