FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies

Phase 1 Active not recruiting 144 enrolled Foghorn Therapeutics Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects with advanced hematologic malignancies.

Timeline

Start: 2021-06-14
Primary completion: 2025-09
Completion: 2027-06

Publications

Results DiNardo CD, Fathi AT, Kishtagari A, Bhalla KN, Quintas-Cardama A, Reilly SA, Almon C, Patriquin C, Nabhan S, Healy K, Hickman D, Collins MP, Khalil A, Corrigan D, Zhao T, Piel J, Lyons K, Horrigan K, Schuck V, Martin P, Elliott G, Lahr DL, Bosinger M, D'Aco K, Smolen GA, Hentemann M, Loghavi S, Agresta S, Savona MR, Stein EM. A Phase I Study of FHD-286, a Dual BRG1/BRM (SMARCA4/SMARCA2) Inhibitor, in Patients with Advanced Myeloid Malignancies. Clin Cancer Res. 2025 Jun 13;31(12):2327-2338. doi: 10.1158/1078-0432.CCR-24-3790.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CAMIBIRSTAT	Small molecule	2.5 mg	Oral
Subject	CAMIBIRSTAT	Small molecule	5 mg	Oral
Subject	CAMIBIRSTAT	Small molecule	7.5 mg	Oral
Subject	CAMIBIRSTAT	Small molecule	10 mg	Oral
Subject	Decitabine	Small molecule	—	Intravenous
Subject	LDAC administered subcutaneously (SC)	Unknown	—	Subcutaneous

FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies

Summary

Timeline

Publications

Drugs

Indications