Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

SHR3680 is administrated orally, qd, 28 days as one cycle. Patients may continue SHR3680 until disease progression or unacceptable toxicity.

SHR3680

Dingwei Ye, M.D.

This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will receive SHR3680.

Androgenic signaling plays a pivotal role in the development of prostate cancer. Androgen deprivation therapy is the mainstay treatment for this cancer in the metastatic setting, but the disease eventually develops to castration-resistant prostate cancer (CRPC) mainly due to the overexpression of androgen receptors (AR) and continued AR activation.

SHR3680 is a novel strong AR antagonist. By competitively binding to AR, SHR3680 inhibits androgen-mediated translocation of AR to the nucleus, binding of AR to Deoxyribonucleic acid (DNA), and finally the transcription of AR target genes, thus possibly resulting in a specific and strong anti-tumor effect on prostate cancer. Unlike first-generation AR antagonists (e.g. bicalutamide), which undergoes an antagonist-to-agonist switch to stimulate AR in the setting of AR overexpression in CRPC, SHR3680 is a full antagonist of AR and thus it is supposed to be more effective for the treatment of CRPC.

A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients

A Phase I/II, Open-Label, Dose-Escalation and -Expansion, Safety, Pharmacokinetics and Efficacy Study of SHR3680 in Patients With Metastatic Castration-Resistant Prostate Cancer

For Phase 1 portion of study; maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the first 12 weeks of multiple dosing

Adverse events are assessed by CTCAE v4.0

Prostate specific antigen (PSA) progression is defined by the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.

Brief Pain Inventory (Short Form), Functional Assessment of Cancer Therapy-Prostate (v4.0)

The time required for the plasma concentration of a drug to be reduced by 50%

Jiangsu HengRui Medicine Co., Ltd.

Immune System Diseases

Rare Diseases

Hypersensitivity

Kennedy Disease

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Hormones

Bicalutamide

Androgen Antagonists

Hormone Antagonists

Participants will receive bicalutamide orally

Tablet. Specifications of 80 mg; orally, once a day

Tablet. Specifications of 50 mg; orally, once a day

The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.

This is an open, multicenter, randomized phase III trial. This clinical study compares the efficacy and safety of SHR3680 with bicalutamide in the patients with hormone sensitive prostate cancer. Approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to SHR3680 or bicalutamide treatment. Primary endpoints of the study are radiological progress-free survival (rPFS) and overall survival (OS).

A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer

Time from randomisation to radiologically confirmed progressive disease or death due to any cause

Time from randomisation to death due to any cause

Time from randomisation to the first time of PSA progression according to the criterion of PCGW3

Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery

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

Time from randomisation to the initiation of antineoplastic subsequent to the study treatment

Participants will receive SHR2554 combined with SHR3680 orally

SHR2554

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 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

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

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

Goserelin

Treatment group: SHR3680 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy).

Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles.

Treatment group ：Placebo 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy).

Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles.

Placebo

Chunlei Jin, M.D.

Dingwei Ye

The study is being conducted to evaluate the efficacy and safety of SHR3680 plus androgen deprivation therapy (ADT) vs. placebo plus ADT in patients with high-risk localized or locally advanced prostate cancer using pathologic complete response (pCR) rate and metastasis-free survival (MFS).

SHR3680 + ADT compared with placebo + ADT

A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy

A Phase III Randomized, Placebo-Controlled, Double-Blind Study of SHR3680 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Patients With High-Risk Localized or Locally Advanced Prostate Cancer Undergoing Radical Prostatectomy

Defined as the proportion of subjects with no residual tumor detected in prostatectomy specimens by H\&E staining and ancillary immunohistochemistry (if necessary) as assessed by pathology BICR.

Defined as the time from the date of randomization to the date of first occurrence of BICR-confirmed radiographic distant metastasis, accidental pathologic finding of distant metastasis, or death from any cause (whichever occurs first), regardless of whether the subject reveives any other anti-tumor therapy or has missing (or unevaluable) tumor assessments.

Defined as the time from the date of randomization to the date of first occurrence of investigator-assessed radiographic distant metastasis to the bone or soft tissue, accidental pathologic finding of distant metastasis, or death from any cause (whichever occurs first), regardless of subsequent anti-tumor treatment or missing (or unevaluable) tumor assessments.

Defined as the proportion of subjects with a ≥ 90% decrease in PSA levels from baseline on Day 1 of Cycle 4.

Defined as the proportion of subjects without tumor cells detected in the margin of prostatectomy pathological specimens following H\&E staining and ancillary immunohistochemistry (if necessary), as assessed by local pathologists.

Defined as the time from the date of randomization to the time of BCR (i.e. two consecutive PSA rise ≥ 0.2 ng/mL following radical prostatectomy).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients	NCT02691975	Hormone Refract... Metastatic Pros...	SHR3680	18 Years - 80 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer	NCT03520478	Prostate Cancer Hormone-Depende...	SHR3680 Bicalutamide	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
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.
A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients	NCT02691975	Hormone Refract... Metastatic Pros...	SHR3680	18 Years - 80 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
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 Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy	NCT05009290	Patients With H...	SHR3680 Placebo	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy	NCT05009290	Patients With H...	SHR3680 Placebo	18 Years -	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for shr3680

Every month we try and update this database with for shr3680 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 shr3680

Every month we try and update this database with for shr3680 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 shr3680 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.