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Efficacy and safety of SHR-2554 in advanced epithelioid sarcoma: A phase 2 trial. (Hall A; Poster Bd #: 475) - Apr 24, 2024 - Abstract #ASCO2024ASCO_757; To be eligible for inclusion, pts had to fulfill the following criteria: 8 years or older; histologically confirmed advanced or metastatic ES with loss of INI1 or upregulated mRNA level of EZH2; progressive disease after at least one line of doxorubicin-containing chemotherapy; the presence of measurable disease according to RECIST 1.1; an ECOG performance status of 0-1. SHR-2554 showed promising efficacy and an acceptable safety profile in pts with refractory ES, warranting further investigation.
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Enrollment open, Trial initiation date: SHR2554 Clinical Study of Chidamide in the Treatment of T-cell Lymphoma (clinicaltrials.gov) - Feb 1, 2024 P3, N=130, Recruiting, SHR-2554 showed promising efficacy and an acceptable safety profile in pts with refractory ES, warranting further investigation. Not yet recruiting --> Recruiting | Initiation date: Nov 2023 --> Feb 2024
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Enrollment closed, Trial completion date, Trial primary completion date: Effect of Fluconazole on Pharmacokinetics of SHR2554 in Healthy Subjects (clinicaltrials.gov) - Mar 7, 2023 P1, N=18, Active, not recruiting, Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> Jun 2023 | Trial primary completion date: Jan 2023 --> May 2023
- |||||||||| SHR2554 / Jiangsu Hengrui Medicine
P1 data, Clinical Trial,Phase I, Journal: SHR2554, an EZH2 inhibitor, in relapsed or refractory mature lymphoid neoplasms: a first-in-human, dose-escalation, dose-expansion, and clinical expansion phase 1 trial. (Pubmed Central) - Jul 8, 2022 P1 No abstract available SHR2554 showed an acceptable safety profile and promising antitumour activity in patients with relapsed or refractory lymphomas, providing evidence for future investigations.
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Enrollment closed, Trial completion date, Trial primary completion date: A Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - Jan 13, 2022 P1, N=28, Active, not recruiting, SHR2554 showed a manageable safety profile and promising anti-tumor activity in pts with r/r lymphomas, supporting further explorations in FL, PTCL, and cHL. Not yet recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> Apr 2022 | Trial primary completion date: Oct 2021 --> Jan 2022
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Enrollment change, Trial completion date, Trial primary completion date: A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms (clinicaltrials.gov) - Feb 5, 2021 P1, N=120, Recruiting, 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. N=42 --> 120 | Trial completion date: Sep 2020 --> Jun 2023 | Trial primary completion date: Sep 2020 --> Jun 2022
- |||||||||| Airui'en (rezvilutamide) / Jiangsu Hengrui Pharma
Enrollment change, Trial completion date, Trial termination, Combination therapy, Metastases: A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC (clinicaltrials.gov) - Feb 5, 2021 P1/2, N=9, Terminated, N=42 --> 120 | Trial completion date: Sep 2020 --> Jun 2023 | Trial primary completion date: Sep 2020 --> Jun 2022 N=100 --> 9 | Trial completion date: Jul 2021 --> Dec 2020 | Recruiting --> Terminated; According to the available data from the trial?the sponsor determined to terminate this study.
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