Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 9, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT05479812). This is a study registration, not published results. Lead sponsor: Werewolf Therapeutics, Inc.. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 156 participants (ACTUAL). Conditions: Metastatic Solid Tumor, Advanced Solid Tumor. Interventions: DRUG: WTX-124; DRUG: pembrolizumab. Primary outcome measures: 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. Brief summary: A first-in-human, Phase I, open-label, multicenter study of WTX-124 administered as monotherapy and in combination with pembrolizumab to patients with advanced or metastatic solid tumors.