^
    21d
    Linperlisib Combined With EZH2 Inhibitor in Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL) (clinicaltrials.gov)
    P1, N=33, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P1 trial • Combination therapy
    |
    SHR-2554 • Itari (linperlisib)
    2ms
    SHR-1701 Combined with SHR2554 and BP102 for MCRC (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Fudan University
    New P2 trial • Metastases
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    3ms
    A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms (clinicaltrials.gov)
    P1, N=272, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Aug 2026 | Trial primary completion date: Feb 2023 --> Feb 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit) • BCL6 (B-cell CLL/lymphoma 6)
    |
    EZH2 mutation
    |
    SHR-2554
    3ms
    A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • SHR-2554 • HRS-5041 • M9466
    4ms
    A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=100, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P1/2 trial • Metastases
    |
    docetaxel • abiraterone acetate • prednisone • SHR-2554 • HRS-5041 • M9466
    4ms
    Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (clinicaltrials.gov)
    P2, N=25, Recruiting, Fudan University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SHR-2554 • ivarmacitinib (SHR0302)
    5ms
    Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Fudan University
    New P2 trial
    |
    SHR-2554 • ivarmacitinib (SHR0302)
    7ms
    A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SHR-2554
    8ms
    A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P2, N=105, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P2 trial
    |
    SHR-2554
    11ms
    A Study to Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Volunteers (clinicaltrials.gov)
    P1, N=6, Completed, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    SHR-2554
    11ms
    SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma (clinicaltrials.gov)
    P3, N=130, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Epidaza (chidamide) • SHR-2554
    1year
    A Study of SHR2554 With Chemotherapy in Treatment-naïve Patients With Peripheral T-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=100, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P1/2 trial
    |
    SHR-2554
    1year
    Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Chinese PLA General Hospital | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Mar 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    1year
    Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy Subjects (clinicaltrials.gov)
    P1, N=20, Completed, Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    SHR-2554 • omeprazole
    1year
    Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy Subjects (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    SHR-2554 • omeprazole
    1year
    SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma (clinicaltrials.gov)
    P3, N=130, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P3 trial
    |
    Epidaza (chidamide) • SHR-2554
    1year
    Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy Subjects (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P1 trial
    |
    SHR-2554
    1year
    A Study to Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Volunteers (clinicaltrials.gov)
    P1, N=8, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    SHR-2554
    over1year
    Preliminary efficacy and safety of SHR-2554 in advanced epithelioid sarcoma: A phase II trial (ESMO 2023)
    Other key inclusion criteria: the presence of measurable disease according to RECIST 1.1; an ECOG performance status of 0-1; progressive disease after at least one line of adriamycin containing chemotherapy; documented loss of SMARCB1 (INI1) alterations or the upregulated mRNA level of EZH2. No serious treatment-related AEs were observed. Conclusions SHR-2554 showed promising efficacy and an acceptable safety profile in pts with refractory ES, warranting further investigation.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1)
    |
    doxorubicin hydrochloride • SHR-2554
    over1year
    SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Chinese PLA General Hospital | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    over1year
    SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=100, Not yet recruiting, Chinese PLA General Hospital
    New P1/2 trial • Combination therapy
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    over1year
    Phase I study of the bifunctional anti-PD-L1/TGF-βRII agent SHR-1701 combined with SHR2554, an EZH2 inhibitor, in patients with previously treated advanced lymphoma and solid tumors. (ASCO 2023)
    16 (100%) cHL pts had received prior anti-PD1/PD-L1 antibody therapy, and 15 ( 93.8%) prior epigenetic therapies, such as decitabine or chidamide. SHR-1701 combined with SHR2554 showed acceptable safety profile and encouraging antitumor activity in immunotherapy-pretreated cHL, establishing the foundation for further exploration. Clinical trial information: NCT04407741.
    Clinical • P1 data • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    decitabine • Epidaza (chidamide) • retlirafusp alfa (SHR-1701) • SHR-2554
    2years
    Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Chinese PLA General Hospital | Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Mar 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    3years
    A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms (clinicaltrials.gov)
    P1, N=231, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | N=120 --> 231 | Trial primary completion date: Jun 2022 --> Feb 2023
    Clinical • Enrollment change • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit) • BCL6 (B-cell CLL/lymphoma 6)
    |
    EZH2 mutation
    |
    SHR-2554
    3years
    MULAN: Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=319, Recruiting, Fudan University | Not yet recruiting --> Recruiting | N=170 --> 319
    Enrollment open • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    Avastin (bevacizumab) • everolimus • AiRuiKa (camrelizumab) • capecitabine • Irene (pyrotinib) • albumin-bound paclitaxel • fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • retlirafusp alfa (SHR-1701) • famitinib (SHR 1020) • SHR-2554 • SHR7390 • Airui'en (rezvilutamide)
    over3years
    The Synergistic Anti-Tumor Activity of EZH2 Inhibitor SHR2554 and HDAC Inhibitor Chidamide through ORC1 Reduction of DNA Replication Process in Diffuse Large B Cell Lymphoma. (PubMed, Cancers (Basel))
    SHR2554, a potent, highly selective small molecule inhibitor of EZH2, inhibited EZH2-mutant DLBCL more significantly in vitro and in vivo. The combination of HDAC inhibitor HBI8000 with EZH2 inhibitor SHR2554 exhibited dramatic anti-tumor activity in both mutant and wild-type DLBCL, which may become a potential therapeutic modality for the treatment of DLBCL patients.
    Journal
    |
    EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit)
    |
    EZH2 mutation • EZH2 overexpression
    |
    Epidaza (chidamide) • SHR-2554
    almost4years
    A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms (clinicaltrials.gov)
    P1, N=120, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | N=42 --> 120 | Trial completion date: Sep 2020 --> Jun 2023 | Trial primary completion date: Sep 2020 --> Jun 2022
    Clinical • Enrollment change • Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit) • BCL6 (B-cell CLL/lymphoma 6)
    |
    EZH2 mutation
    |
    SHR-2554
    4years
    Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Chinese PLA General Hospital | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    over4years
    Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=100, Not yet recruiting, Chinese PLA General Hospital | Initiation date: Jun 2020 --> Sep 2020
    Clinical • Trial initiation date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    over4years
    Phase Ⅰ/Ⅱ Study of SHR2554 in Combination With SHR1701 in Patients With Advanced Solid Tumors and B-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=100, Not yet recruiting, Chinese PLA General Hospital
    Clinical • New P1/2 trial • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    retlirafusp alfa (SHR-1701) • SHR-2554
    over4years
    MULAN: Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=170, Not yet recruiting, Fudan University
    New P2 trial • BRCA Biomarker • PD(L)-1 Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • PGR positive
    |
    everolimus • AiRuiKa (camrelizumab) • capecitabine • Irene (pyrotinib) • albumin-bound paclitaxel • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • retlirafusp alfa (SHR-1701) • famitinib (SHR 1020) • SHR-2554 • SHR7390 • Airui'en (rezvilutamide)