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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

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment125

FDA Designations

No designations recorded

Clinical trial landscape

WTX-330 · 2 trials · 2 indications

Phase 1 2
NCT06939283A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or LymphomaAdvanced or Metastatic Solid Tumors
ACTIVE NOT_RECRUITING100 Analytics
NCT05678998WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin LymphomaAdvanced or Metastatic Solid Tumors
COMPLETED25 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Lymphoma
Advanced or Metastatic Solid TumorsUnlock trial analytics
PHASE1COMPLETED
WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
Advanced or Metastatic Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced or Metastatic Solid Tumors")

Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT06939283primaryCompletionDate: changed
LOWMay 24, 2026NCT06939283studyFirstPostDate: changed

Frequently asked questions about WTX-330

What is WTX-330 used for?

WTX-330 is an investigational small molecule being developed for the treatment of advanced or metastatic solid tumors and non-Hodgkin lymphoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes WTX-330?

WTX-330 is being developed by Werewolf Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol HOWL. The company is conducting clinical trials of WTX-330 in the United States.

What phase is WTX-330 in?

WTX-330 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been conducted, one completed and one active but not recruiting.

What clinical trials is WTX-330 in?

WTX-330 has been studied in two clinical trials. NCT05678998 was a completed Phase 1 study in patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. NCT06939283 is an active Phase 1b/2 study in the same patient populations.

Is WTX-330 the same as any other drug?

WTX-330 is a distinct investigational small molecule developed by Werewolf Therapeutics. No alternative names for WTX-330 have been reported in the clinical trial information.