Trial Profile

A Modular, Multi-part, Multi-arm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination With Anticancer Treatments in Patients With Solid Malignancies

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 21 Jun 2025

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At a glance

Drugs Cemiplimab (Primary) ; GRWD 5769 (Primary)
Indications Cervical cancer; Head and neck cancer; Liver cancer; Solid tumours; Squamous cell cancer
Focus Adverse reactions; First in man
Acronyms EMITT-1
Sponsors Grey Wolf Therapeutics

11 Apr 2025 Planned End Date changed from 30 Sep 2025 to 30 Apr 2028.
11 Apr 2025 Planned primary completion date changed to 30 Apr 2027.
04 Jun 2024 Results (As of 03 January 2024, n=12 ) assessing safety, pharmacokinetic (PK) and pharmacodynamic (PD) endpoints from Part A (monotherapy dose escalation) presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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