Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants will receive SHR2554 combined with SHR3680 orally

SHR3680

SHR2554

Dingwei Ye, M.D.

The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.

This is a multicenter, open, non-randomized and dose-escalating and -expansion Phase I/II trial and it studies the tolerance, PK and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. The Phase I part is a dose-escalating study including Ia (dose-escalation monotherapy) and Ib (dose-escalation combination therapy). Approximately 18-30 patients in Phase Ia will only receive one of five dose levels of orally SHR2554. Approximately 30\~48 patients in Phase Ib trial will receive SHR2554 combined with SHR3680, in which 2\~3 different dose levels of SHR2554 will be selected based on the result of the Phase Ia. Phase II part is a dose-expansion study. Primary endpoints of the study are dose-limiting tolerance (DLT), maximum-tolerated dose (MTD) and prostate specific antigen (PSA) response rate.

A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC

A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer

A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents

The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations

After the continuous therapy from randomisation to the end of the 12 weeks, the ratio of patients whose levels of PSA decreased more than 50%

Time from randomisation to the first time of PSA progression according to the criteria of the Prostate Cancer Clinical Trials Working Group 3 （PCWG3)

The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

The single dose and multiple dose PK will be calculated as data permits including Area AUC

The single-dose and multiple dose PK will be calculated as data permits including Cmax

The type, frequency, severity, timing, seriousness, and relationship to study therapy

Jiangsu HengRui Medicine Co., Ltd.

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Amino Acids

Antibodies

Capecitabine

Paclitaxel

Bevacizumab

Everolimus

Fulvestrant

Albumin-Bound Paclitaxel

Sirolimus

Immunoglobulins

Aromatase Inhibitors

Tyrosine Kinase Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Temsirolimus

MTOR Inhibitors

Androgen Receptor Antagonists

Fluzoparib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Tyrosine

If a patient were NF1 mutated, she would receive SHR7390(MEK1/2 inhibitor) and Faminitib.

If a patient were gBRCA mutated, she would receive SHR3162 (PARP inhibitor)and SHR6390(CDK4/6 inhibitor) .

If a patient were HER2 activated mutated and had not previously used capecitabine, she would receive Pyrotinib and Capecitabine , while if the patient have previously used capecitabine, she would only use pyrotinib as a single agent.

If a patient were PDGFRb mutated, she would receive Faminitib.

In the arm which IHC showed CD8 ≥10%, this arm will be subdivided into 6 sub-arms, in which Arm 5A-4D, we choose the patients who had CDK4/6 inhibitor before while in Arm 5E, we choose the patients who secondarily resistant to adjuvant endocrine therapy , and in Arm 5FF, we choose the patients who is in stage IV without precious treatment or sensitively recurrence. A patient would receive SHR1210(PD-1 antibody) ,nab-paclitaxel and Faminitib in Arm-5A. A patient would receive SHR1210(PD-1 antibody) and VEGF inhibitor in Arm-5B. A patient would receive SHR1701(PD-L1/TGF-βRII inhibitor) in Arm-5C. A patient would receive SHR1701(PD-L1/TGF-βRII inhibitor) and SHR6390(CDK4/6 inhibitor) in Arm-5D. A patient would receive SHR1210(PD-1 antibody) and SHR6390(CDK4/6 inhibitor) and SERD in Arm-5E. A patient would receive SHR1210(PD-1 antibody) and SHR6390(CDK4/6 inhibitor) and AI in Arm-5F.

If a patient had any PAM pathway mutation, she would receive Everolimus(mTOR inhibitor) combined with nab-paclitaxel.

If a patient's IHC showed AR≥10% , she would receive SHR2554(EZH2 inhibitor) and SHR3680(AR inhibitor).

In this cohort, a patient would receive SHR2554(EZH2 inhibitor) and SHR3162 (PARP inhibitor).

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1701(anti-PD-L1/TGF-βRII bifunctional fusion protein) .

SHR7390

Famitinib

SHR3162

HER1 / HER2 receptor tyrosine kinase inhibitor

Pyrotinib

In Arm III, if the patient had not previously used capecitabine,she would receive pyrotinib and capecitabine, if the patients have previously used capecitabine, she would only used pyrotinib as a single agent.

SHR1210

Nab paclitaxel

SHR6390

anti-PD-L1/TGF-βRII bifunctional fusion protein

SHR1701

SERD

VEGFi

Zhi-Ming Shao

Zhong-Hua Wang

Zhimin Shao, MD, PhD

This study is a prospective, single-center, open-label, umbrella-shaped phase II clinical study for patients with HR+/HER2- endocrine-resistant advanced breast cancer.

Seven precision treatment cohorts, which targeting NF1 mutation, gBRCA mutation,HER2 mutation, FDGFRb mutation PAM pathway mutations, CD8 and AR, as long as an epigenetic therapy cohort and a combined immunization cohort were initially set up based on gene expression profiles and molecular pathways. The main purpose is to screen valuable treatment cohorts and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer

Precision Treatment of Luminal Advanced Breast Cancer Based on Molecular Subtyping

The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the evaluable subjects

time to progressive disease (according to RECIST1.1)

Fudan University

Professor, Key Laboratory of Breast Cancer in Shanghai, Department of Breast Surgery

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Zhenyu Xiao

Yuqin Song

The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma

A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma

A Phase II, Single-arm, Open-label, Multicenter Study on the Efficacy of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma

percentage of patients who achieve completes response(CR) or partial response(PR) in the study

percentage of patients who achieve CR or PR in the study

time from the first dose of SHR2554 to the first disease progression(PD) or death

time from the first dose of SHR2554 to first CR or PR

time from the first CR or PR to the first PD or death

time from the fist dose of SHR2554 to death

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Peripheral T-cell Lymphoma

Apatinib

Azacitidine

Dasatinib

T1 subtypes based on next generation sequencing results

T2 subtypes based on next generation sequencing results

T3.1 subtypes based on next generation sequencing results

T3.2 subtypes based on next generation sequencing results

Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes

Azacitidine Injection

Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes

Linperlisib

Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes

Tucidinostat

Camrelizumab and Apatinib will be administered in T3.2 subtypes

Camrelizumab

Weili Zhao

Pengpeng Xu

Weili Zhao, M.D. and Ph.D

This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.

A Umbrella Study in R/R PTCL Guided by Molecular Subtypes

A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes

Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

Overall survival was defined as the time from the date of enrollment to the date of death from any cause.

Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria

An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Ruijin Hospital

First Deputy Director, Hematology Department

Oculocerebral Syndrome With Hypopigmentation

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of SHR2554 Tablets in healthy subjects.

Randomized, open-label, single-dose, two-cycle, two-sequence, cross-controlled

Pharmacokinetic Test of High-fat Diet After Oral Administration of SHR2554 in Healthy Subjects

A Randomized, Open-label, Single-dose, Two-cycle, Two-sequence, Cross-controlled Study Evaluating the Pharmacokinetic Effects of a High-fat Diet on Oral Administration of SHR2554 Tablets in Healthy Adult Subjects in China

Lysine

Part I：treated with escalated doses of EZH2 inhibitor SHR2554 respectively； Part II：treated with fixed dose (RP2D) SHR2554 respectively

SHR2554 is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2.

Weiwei Wang, MD

Jun Zhu, MD

Lin Shen, M.D

This is a Phase 1 multicenter, single-arm, open-label, dose escalation and dose expansion study of enhancer of zeste homolog 2 (EZH2 ) inhibitor SHR2554.

This study will assess the tolerability, safety, pharmacokinetics, and preliminary anti-tumor activity of SHR2554 in participants with relapsed or refractory mature lymphoid neoplasms in part I, and the the efficacy in PTCL patients will be studied in Part II.

A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms

A Phase 1 Study to Characterize Safety, Tolerance, Pharmacokinetics and Efficacy of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms

Analyze the level of H3K27me3 in the peripheral blood mononuclear cells of the subjects before and after the treatment of escalated doses of SHR2554.

Assess the known mutation of EZH2 gene in tumor cells or tissues, analyze the relationship between efficacy and EZH2 mutation

Assess EZH2 expression level in tumor tissues, analyze the relationship between efficacy and EZH2 expression level

The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of SHR2554 will be assessed.

Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of SHR2554.

assessed by independent radiology review committee (IRC)

Pharmacokinetics profile of a single dose SHR2554 and its metabolite (plasma): Time to peak (Tmax) of plasma concentration

Pharmacokinetics profile of a single dose SHR2554 and its metabolite (plasma): Maximum plasma concentration (Cmax)

Pharmacokinetics profile of a single dose SHR2554 and its metabolite (plasma): Halflife (T1/2)

Pharmacokinetics profile of a single dose SHR2554 and its metabolite (plasma): Clearance/ bioavailability (CL/F)

Pharmacokinetics profile of a single dose SHR2554 and its metabolite (plasma): apparent volume of distribution/bioavailability (Vd/F)

Pharmacokinetics profile of a single dose SHR2554 and its metabolite (plasma): Area under curve (AUC)

Pharmacokinetics profile of continuous medication of SHR2554 and its metabolite (plasma): Area under curve, steady state (AUCss)

Pharmacokinetics profile of continuous medication of SHR2554 and its metabolite (plasma): Maximum plasma concentration, steady state (Cmax,ss)

Pharmacokinetics profile of continuous medication of SHR2554 and its metabolite (plasma): Time to peak, steady state (Tmax,ss)

Pharmacokinetics profile of continuous medication of SHR2554 and its metabolite (plasma): Halflife (T1/2)

Pharmacokinetics profile of continuous medication of SHR2554 and its metabolite (plasma): Apparent volume of distribution, steady state/bioavailability (Vss/F)

Pharmacokinetics profile of continuous medication of SHR2554 and its metabolite (plasma): Clearance/ bioavailability (CL/F)

Pharmacokinetics profile of continuous medication of SHR2554 and its metabolite (plasma): Accumulation index (Rac)

Assess the response rate of subjects to the treatment of SHR2554

Assess the survival condition of the subjects after the treatment of SHR2554

Assess the duration of complete/partial response after the treatment of SHR2554

Assess the time to initial response of subjects to the treatment of SHR2554

Assess the overall survival of subjects treated by SHR2554

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC	NCT03741712	Prostate Cancer Castration-resi...	SHR3680 SHR2554	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma	NCT06368167	Follicular Lymp...	SHR2554	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes	NCT05559008	Peripheral T Ce...	Azacitidine Inj... Dasatinib Linperlisib Tucidinostat SHR2554 Camrelizumab Apatinib	18 Years -	Ruijin Hospital
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
A Umbrella Study in R/R PTCL Guided by Molecular Subtypes	NCT05559008	Peripheral T Ce...	Azacitidine Inj... Dasatinib Linperlisib Tucidinostat SHR2554 Camrelizumab Apatinib	18 Years -	Ruijin Hospital
Pharmacokinetic Test of High-fat Diet After Oral Administration of SHR2554 in Healthy Subjects	NCT05592262	Malignant Tumor	SHR2554 SHR2554	18 Years - 45 Years	Jiangsu HengRui Medicine Co., Ltd.
Pharmacokinetic Test of High-fat Diet After Oral Administration of SHR2554 in Healthy Subjects	NCT05592262	Malignant Tumor	SHR2554 SHR2554	18 Years - 45 Years	Jiangsu HengRui Medicine Co., Ltd.
A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma	NCT06368167	Follicular Lymp...	SHR2554	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
A Phase 1 Study of SHR2554 in Subjects With Relapsed or Refractory Mature Lymphoid Neoplasms	NCT03603951	Relapsed or Ref...	SHR2554	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for shr2554

Every month we try and update this database with for shr2554 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for shr2554

Every month we try and update this database with for shr2554 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for shr2554 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.