drugset / Trial / NCT04407741

Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas

NCT04407741

Phase 1/2 Unknown 100 enrolled Chinese PLA General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The potency of immune checkpoint blockade is limited in most solid malignancies, one possible reason for which is tumor microenvironment. Enhancer of zeste homolog 2 (EZH2) as a epigenetic target for cancer therapy has attracted significant interest. The combination of EZH2 inhibitors and programmed death-1 ligands/ transforming growth factor-β (PD-L1/TGFβ) blockade may enhance the efficiency of immunotherapy.The primary objective of this study in phase Ⅰstage is to assess the safety, feasibility of EZH2 inhibitor SHR2554 in combination with anti-PD-L1/TGFβ antibody SHR1701 in advanced pretreated solid tumors and b-cell lymphomas. The phase Ⅱ stage of this study is to primarily evaluate the efficacy of SHR2554 plus SHR1701 and the epigenetic modulating effect of SHR2554.

Timeline

Start
2020-09-01
Primary completion
2024-12-01
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Retlirafusp alfa Protein / enzyme biologic 30 mg/kg Intravenous
Subject SHR2554 Small molecule Oral

Indications