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WTX-124

Phase 1

Metastatic Solid Tumor | Small molecule | Oncology |Werewolf Therapeutics, Inc.|Last Updated: Aug 27, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment156

FDA Designations

FAST_TRACK

Clinical trial landscape

WTX-124 · 1 trial · 2 indications

Phase 1 1
NCT05479812Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid TumorsMetastatic Solid Tumor
COMPLETED156 Analytics
PHASE1COMPLETED
Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid Tumors
Metastatic Solid TumorUnlock trial analytics

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 to 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 (matched to "Metastatic Solid Tumor")

Recent Changes (Last 90 Days)

HIGHAug 27, 2026NCT05479812Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 27, 2026NCT05479812Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about WTX-124

What is WTX-124 used for?

WTX-124 is an investigational small molecule being developed for the treatment of metastatic solid tumors. It is currently in Phase 1 clinical development, and the completed trial studied it as a monotherapy and in combination with pembrolizumab in patients with selected advanced or metastatic solid tumors.

Who makes WTX-124?

WTX-124 is being developed by Werewolf Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol HOWL. The company is conducting clinical research on this investigational oncology drug.

What phase is WTX-124 in?

WTX-124 is in Phase 1 clinical development. The completed trial was a dose escalation and expansion study. It is an investigational drug and has not been approved by regulatory authorities. The FDA has granted it Fast Track designation.

What clinical trials is WTX-124 in?

WTX-124 has one completed clinical trial, identified as NCT05479812. This Phase 1 study evaluated WTX-124 as monotherapy and in combination with pembrolizumab in patients with selected advanced or metastatic solid tumors. The trial enrolled 156 participants in the United States.

Is WTX-124 FDA approved?

No, WTX-124 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The FDA has granted it Fast Track designation, which is intended to expedite development and review, but approval has not been granted.