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
← catalyst calendarSponsored by Werewolf Therapeutics, Inc. (industry) · HOWL — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
150estimated
Sites
14
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-05-20 | actual | When the study began enrolling |
| Primary completion | 2026-07-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-07-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Metastatic Solid Tumor
- Advanced Solid Tumor
Interventions
- Drug: WTX-124
- Drug: pembrolizumab — also filed as KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFIncidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
measured 4 weeks
Incidence of treatment emergent adverse events in monotherapy and combination therapy
measured 24 months
Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
measured 24 months
Dose Expansion - Incidence of Dose Limiting Toxicities (DLTs) in monotherapy and combination therapy
measured 4 weeks
Dose Expansion - Incidence of treatment emergent adverse events in monotherapy and combination therapy
measured 24 months
Dose Expansion - Incidence of changes in clinical laboratory abnormalities in monotherapy and combination therapy
measured 24 months
Dose Expansion - Investigator-assessed objective response rate (ORR) per RECIST 1.1 and iORR by iRECIST in monotherapy and combination therapy
measured 24 months
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