AiRuiJing (zeprumetostat) / Jiangsu Hengrui Pharma, Treeline Biosci - LARVOL DELTA

A case report: axillary ALK-positive anaplastic large-cell lymphoma mimicking an infectious abscess in an adolescent. (PubMed, Front Oncol) - "The patient was transferred to hematology and received initial cytoreductive therapy with brentuximab vedotin and short-course zeprumetostat, after which the local tumor burden decreased and delayed wound closure was performed. She subsequently received five cycles of brentuximab vedotin plus CHP and chidamide maintenance after complete remission. A presumed abscess that yields little pus but contains solid friable tissue should not be managed as infection alone. In refractory, culture-negative, or biologically discordant soft-tissue lesions, early biopsy of the cavity wall and solid components may help reduce diagnostic delay and redirect care toward malignancy-specific treatment."

Journal • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • T Cell Non-Hodgkin Lymphoma • ALK • TNFRSF8

Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC (clinicaltrials.gov) - P2 | N=55 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

EpiRev-NKT: Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=107 | Recruiting | Sponsor: Rong Tao | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Retlirafusp alfa Combined with Rivoceranib, With or Without Zeprumetostat, in Patients with Advanced Gastric Cancer Who Have Failed First-Line Immunotherapy (ESMO 2026) - No abstract available

Clinical • Metastases • Gastric Cancer • Oncology • Solid Tumor

SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Henan Cancer Hospital | Not yet recruiting ➔ Recruiting | N=60 ➔ 30

Enrollment change • Enrollment open • Breast Cancer • Oncology • Solid Tumor

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=351 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

EpiRev-NKT: Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=107 | Not yet recruiting | Sponsor: Rong Tao

New P1/2 trial • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Evaluation of the effectiveness and safety of Zeprumetostat, the EZH2 inhibitor applied on the advanced malignant bone and soft tissue tumor: a single-center, single-arm, phase 2 study (ChiCTR) - P2 | N=32 | Not yet recruiting | Sponsor: Shanghai Changzheng Hospital; The Second Affiliated Hospital of Naval Medical University (Shanghai Changzheng Hospital)

New P2 trial • Oncology • Osteosarcoma • Solid Tumor

MULAN: Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=319 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting | N=170 ➔ 319

Enrollment change • Enrollment open • Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Clinical Study of EZH2 Inhibitor Combined With PARP Inhibitor in the Treatment of Patients With Advanced or Recurrent Epithelial Ovarian Cancer. (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Peking University Third Hospital

New P2 trial • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2

A Prospective, Single-Arm, Phase Ib/II Clinical Study of the EZH2 Inhibitor Zeprumetostat in Combination with Glofitamab plus GemOx for the Treatment of Relapsed/Refractory DLBCL (ChiCTR) - P4 | N=52 | Not yet recruiting | Sponsor: Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi

New P4 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P2 | N=351 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

A clinical study of Zeprumetostat in combination with azacitidine for MDS patients who have no response, relapse, or disease progression after prior first-line therapy. (ChiCTR) - P4 | N=78 | Not yet recruiting | Sponsor: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

New P4 trial • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

MULAN: Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=170 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination with Other Antitumor Therapies in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma (ChiCTR) - P2 | N=366 | Recruiting | Sponsor: Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • HER-2 • PD-L1

SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Henan Cancer Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor

An Open-Label, Single-Arm, Single-Center Clinical Trial of Zeprumetostat in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: Shandong First Medical University Affiliated Dermatology Hospital; Shandong First Medical University Affiliated Dermatology Hospital

New trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Clinical Study on the Efficacy and Safety of Zeprumetostat, Azacitidine Combined with Lipo-MIT in Relapsed/Refractory Peripheral T-Cell Lymphoma. (ChiCTR) - P2 | N=26 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University

New P2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Linperlisib Combined With EZH2 Inhibitor in Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Prospective Clinical Study of Zeprumetosta in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Peking University First Hospital

New P2 trial • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

ENHANCER OF ZESTE HOMOLOG 2 (EZH2) INHIBITOR SHR2554 IN RELAPSED OR REFRACTORY (R/R) PERIPHERAL T-CELL LYMPHOMA (PTCL): UPDATED OUTCOMES FROM THE FIRST-IN-HUMAN PHASE 1 STUDY (ICML 2023) - P1 | "This extended follow-up analysis further provides evidence of potent anti-tumor activity, durable response, and acceptable safety of SHR2554 in pts with r/r PTCL."

P1 data • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A PIVOTAL STUDY OF SHR2554, AN ORAL INHIBITOR AGAINST ENHANCER OF ZESTE HOMOLOG 2 (EZH2), IN RELAPSED OR REFRACTORY (R/R) PERIPHERAL T-CELL LYMPHOMA (PTCL) (EHA 2025) - P1, P3 | "All patients had received chemotherapy regimens; moreover, all patients had been treated with tucidinostat or brentuximab vedotin (tucidinostat, 59 [88.1%]; brentuximab vedotin, 21 [31.3%]; both, 13 [19.4%]). The pivotal study met its primary endpoint, demonstrating that SHR2554 is efficacious and has a manageable safety profile in patients with r/r PTCL. Our findings position SHR2554 as a new potential therapeutic option for this challenging-to-treat population. A randomized controlled phase 3 study comparing SHR2554 with standard therapy for r/r PTCL is currently underway (ClinicalTrials.gov, NCT06122389)."

Anemia • Hematological Disorders • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK • EZH2

A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL) (clinicaltrials.gov) - P1/2 | N=44 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P1/2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Multi-Cohort Study of Zeprumetostat Combinations for Relapsed/Refractory PTCL (clinicaltrials.gov) - P1/2 | N=33 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New P1/2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma