Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

Phase 1 Active not recruiting 60 enrolled Royal Marsden NHS Foundation Trust Astex Pharmaceuticals, Inc. · collab Institute of Cancer Research, United Kingdom · collab Merck Sharp & Dohme LLC · collab

Non-randomizedParallel-groupOpen-labelHealth-services research

Summary

HyPeR is a multi-centre Phase 1 Dose Escalation Study of Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent in Combination with Pembrolizumab (MK3475) in Patients with Refractory Solid Tumours. The investigators will be investigating the safety and toxicity of the combination.

Timeline

Start: 2017-01-26
Primary completion: 2026-09
Completion: 2026-09

Publications

Results Papadatos-Pastos D, Yuan W, Pal A, Crespo M, Ferreira A, Gurel B, Prout T, Ameratunga M, Chenard-Poirier M, Curcean A, Bertan C, Baker C, Miranda S, Masrour N, Chen W, Pereira R, Figueiredo I, Morilla R, Jenkins B, Zachariou A, Riisnaes R, Parmar M, Turner A, Carreira S, Yap C, Brown R, Tunariu N, Banerji U, Lopez J, de Bono J, Minchom A. Phase 1, dose-escalation study of guadecitabine (SGI-110) in combination with pembrolizumab in patients with solid tumors. J Immunother Cancer. 2022 Jun;10(6):e004495. doi: 10.1136/jitc-2022-004495.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASTX727	Unknown	—	Oral
Subject	Guadecitabine	Oligonucleotide (other)	30 mg/m2	Subcutaneous
Subject	Guadecitabine	Oligonucleotide (other)	45 mg/m2	Subcutaneous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

Summary

Timeline

Publications

Drugs

Indications