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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 13, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06923761). This is a study registration, not published results. Lead sponsor: Grey Wolf Therapeutics. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Advanced Solid Malignancy. Interventions: DRUG: Module 1 (GRWD5769 on its own as monotherapy); DRUG: Module 2 (GRWD5769 in combination with cemiplimab, administered IV). Primary outcome measures: Number of treatment emergent and treatment related AEs , From first dose to 30 days after last dose of GRWD5769 for Module 1 and 90 days after last dose of cemiplimab for Module 2 Parts A-C.; Incidence of Dose limiting toxicities (DLT) , End of cycle 1 (each cycle is 21 days); Comparative efficacy (for Module 2D only) , From baseline to week 16. Brief summary: This is a Phase I/II, open-label, first-in human study of GRWD5769 alone, and in combination with another anti-cancer agent in advanced solid cancers.