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WTX-330

Phase 1

Advanced or Metastatic Solid Tumors | Small molecule | Oncology |Werewolf Therapeutics, Inc.|Last Updated: Feb 10, 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 Trials2
Total Enrollment125
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06939283A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or LymphomaPHASE1 ACTIVE NOT_RECRUITING 100May 7, 2025Aug 1, 2028Feb 10, 20265 United States
NCT05678998WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin LymphomaPHASE1 COMPLETED 25Dec 6, 2022Feb 5, 2025Jan 6, 20269 United States
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities (DLTs)
4 weeks
Incidence of treatment emergent adverse events
24 months
Incidence of changes in clinical laboratory abnormalities
24 months
Overall response rate (ORR) by response evaluation criteria in solid tumors (RECIST) 1.1 and the immune-overall response rate (iORR) by immune RECIST (iRECIST; Part 2, Arms A and B) or response by Lugano classification (Part 2, Arm C)
24 months
Duration of response (DOR) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)
24 months
Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas)
24 months

RECIST = Response Evaluation Criteria in Solid Tumors

Secondary Endpoints
Characterize the plasma concentrations of WTX-330, free IL-12 and interferon gamma (IFNγ)
24 months
Changes in PD-L1 expression in tumor biopsies
24 months
Duration of response (DOR) by response evaluation criteria in solid tumors (RECIST) 1.1 and immune RECIST (iRECIST; Part 1 and Part 2, Arms A and B) or based on Lugano classification (Part 2, Arm C)
24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose- and Regimen FindingEXPERIMENTALRegimen 1 Fixed Dose for 28 days then Regimen 2 Step-up Dose for 28 days
Dose Expansion Arm AEXPERIMENTALn\~20 Patients with locally advanced or metastatic cutaneous malignant melanoma who have been treated with a standard of care (SOC) checkpoint inhibitor (CPI) regimen and who demonstrate primary or secondary resistance to this therapy
Dose Expansion Arm BEXPERIMENTALn\~20 Patients with locally advanced or metastatic microsatellite-stable (MSS) colorectal carcinoma (CRC) who have progressed on or are intolerant of SOC therapies and who are naïve to immunotherapy
Dose Expansion Arm CEXPERIMENTALn\~20 Patients with advanced NHL who are relapsed/refractory to SOC therapies and who are CPI naïve
WTX-330 dose escalationEXPERIMENTALPatients with relapsed/refractory advanced or metastatic solid tumors
WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A)EXPERIMENTALWTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B)EXPERIMENTALWTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
Interventions
NameTypeDescription
WTX-330DRUGInvestigational Product
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Age ≥ 18 years, 2. Dose escalation (Part 1): Patients with relapsed/refractory locally advanced or metastatic solid tumor for which the patient has progressed on or is intolerant of standard therapy, or for whom no standard therapy with proven benefit exists. Patients with ca...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06939283primaryCompletionDate: changed
LOWMay 24, 2026NCT06939283studyFirstPostDate: changed