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

Antineoplastic Agents

All Drugs and Chemicals

Fluzoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants will receive Abiraterone combined with SHR3162 orally

Abiraterone+SHR3162

The aim of this trial is to evaluate the Drug-Drug interaction with Abiraterone combined with SHR3162 in the Metastatic Castration Resistant Prostate Cancer Patients.

This is a multicenter, open-label Phase I trial and the aim of this trial is to evaluate the drug-drug interaction and safety with SHR3162 combined with Abiraterone in Metastatic Castration Resistant Prostate Cancer Patients. The trial is a dose-escalation and -expansion study. Approximately 35\~38 patients in will receive fixed- dose of orally Abiraterone and only one of two dose levels of orally SHR3162. The Primary endpoints are incidence of adverse events(AE) and PK characteristics. The secondary endpoints are efficacy and recommended phase 2 dose(RP2D).

A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC

A Phase I Clinical Study of Abiraterone Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer

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

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

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

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

Jiangsu HengRui Medicine Co., Ltd.

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

Temsirolimus

MTOR Inhibitors

Androgen Receptor Antagonists

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Protein Kinase 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

SHR2554

SHR3680

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

3 to 6 participants (traditional "3+3" design) will be enrolled in 6 dose levels. SHR3162 was administered once daily in dose levels 1 and 2 and will be administered twice daily in dose levels 3 to 6.

SHR3162 capsule(s) is administered orally QD.

This is an open-label, multicenter, non-randomized, dose-escalation phase 1 trial to evaluate the safety and tolerability of SHR3162 in participants with advanced solid tumors.

Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) is a family of proteins that plays important roles in multiple cellular processes, including single-strand DNA breaks, which if left unrepaired, leads to double-strand breaks (DSB) during DNA replication. The DSB can be repaired either through error-free homologous recombination (HR) or error-prone non-homology end joining. In HR deficient cancer cells with mutations on HR genes such as BRCA1, BRCA2 or partner and localizer of BRCA2 (PALB2), DSB cannot be efficiently and correctly repaired, resulting in cell death. Viable cells, on the other hand, have normal HR and do not replicate as often as cancer cells; thus they can survive PARP inhibition. PARP inhibitors are being actively developed worldwide as promising anti-tumor therapeutics. The current trial will be conducted in participants with advanced solid tumors for whom satisfactory treatments are not yet available.

In the dose-escalation phase, patients will be enrolled sequentially into the 8 dose levels of SHR3162 designated in this study(3-6 patients per cohort). One to two sentinel participants in Cohort 1 who will be treated and closely monitored for 24 hours. If no adverse effects are noted during the 24-hour period, dosing of further participants in the cohort may continue.

In the dose expansion part of the study, up to 12 additional participants will be enrolled at the MTD.

A Phase I Trial of SHR3162 in Subjects With Advanced Solid Tumors

A Multicenter, Open-Label, Phase 1 Trial of SHR3162 Given Orally to Subjects With Advanced Solid Tumors

MTD will be defined as the maximum dose level at which no more than one 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing

Atridia Pty Ltd.

Death

Antibodies, Monoclonal

Immunoglobulin G

Immunoglobulins, Intravenous

Total 60-100 subjects with advanced solid tumors

In the two-drug combination therapy,subjects were received single oral doses of SHR7390，then accepted two drug combination therapy, SHR7390 is administered multiple daily oral doses of SHR7390 for 28 days for a treatment cycle. At the same time, SHR-1210 was given intravenously per 2 weeks at the 200mg fixed dose.

In the second study part, subjects accepted three drug combination therapy, SHR7390 is administered orally for 21 days and discontinued for 7 days in a 28-day treatment cycle,SHR3162 was administered orally twice a day for 28 days at a fixed dose of 100 mg. At the same time, SHR-1210 was given intravenously per 2 weeks at the 200mg fixed dose

SHR7390 is provided as white, film-coated,immediate release tablets containing SHR7390 at dosage strengths of 0.125 mg,0.5 mg and 2mg. Multiple tablets of SHR7390 will be administered orally to achieve targeted doses of SHR7390: 0.125 mg-4 mg. Tablets will be administered once daily or for 21 days and discontinued for 7 days with 240 ml water after 2 hours of the meal.

SHR-1210 is a humanized anti-PD1 immunoglobulin G4 (IgG4) monoclonal antibody. SHR-1210 is provided as the lyophilized powder,200 mg/vial.SHR-1210 was given with 200mg fixed dose intravenously per 2 weeks at the D1 and D15.Intravenous infusion over 30 min

SHR-1210

SHR3162 is provided as capsules containing SHR3162 at dosage strengths of 10mg,40mg and 100mg. The capsule of SHR3162 will be orally administered with 240ml water twice a day to achieve targeted doses of SHR3162 and the interval of SHR3162 capsules taken twice a day is about 12 hours.

RuiHua Xu, MD, PhD

The study consists of the two parts, the first one is SHR7390 combined with SHR-1210, the second one is SHR7390 combined with SHR-1210 and SHR3162. Two parts of the study are separately to assess the safety and tolerability, to define dose limiting toxicity（DLT) and maximum tolerated dose (MTD),to evaluate the pharmacokinetics ,to assess the antitumor activity in patients with advanced solid tumors preliminarily and to recommend reasonable dosage regimen of SHR7390 for the follow-up clinical trial.

This is a phase I, open-label,two parts,dose escalation/expansion clinical study.The safety,tolerance,PK and preliminary efficacy of two-drug combination and three-drug combination were evaluated respectively in the patients with advanced solid tumors that have no any targeted agents as the standard therapies.

In the first study part, subjects receiving a single dose of SHR7390 (Run-in) are observed in 7-10 days, then accepted two drug combination therapy, SHR7390 is administered once daily orally for 28 days for a treatment cycle. At the same time, SHR-1210 was given intravenously per 2 weeks at the fixed dose of 200mg.

In the second study part, subjects accepted three drug combination therapy, SHR7390 is administered orally for 21 days and discontinued for 7 days in a 28-day treatment cycle,SHR3162 was administered orally twice a day for 28 days at a fixed dose of 100 mg. At the same time, SHR-1210 was given intravenously per 2 weeks at the fixed dose of 200mg.

Dose limiting toxicities (DLT) in the first study part will be assessed during the Run-in and first cycle of treatment. the dose escalation is designed by Accelerated Titration Designs during initial accelerated phase. when the significant toxicity or DLT is observed in the Run-in and first cycle of treatment,the accelerated titration trial terminates and subsequent dose escalations are become a conventional design of 3+3 patients. If one adverse event （AE） meets dose limiting toxicity (DLT) criteria at a given dose, 3 additional patients will be enrolled in this dose cohort. If 2 DLTs are determined at a given dose level, the previous dose will be designated as the MTD.

Based on preliminary determination of RP2D and sufficient safety data in the first part of the study, the second part of three-drug combination will be carried out. the preset dose of SHR7390 includes RP2D initially determined in the first part of the study and its previous low dose level (for example, RP2D is 0.5 mg/d, while the former low dose is 0.25 mg/d). Dose escalation is a conventional design of 3+3 patients.

Additional patients will be enrolled for pharmacokinetic (PK) evaluations at different dose levels based on preliminary safety and tolerability.Each dose level can expand at least 12 subjects , of which 9-12 subjects are PK subjects. Multiple blood samples at designated time points will be collected for PK evaluations (more than 12 subjects are determined by SMC).

The safety, tolerability and AEs will be closely monitored throughout the study duration. The preliminary effectiveness and clinical benefits of two-drug combination and three-drug combination will be evaluated.

The Study of SHR7390 in Combination With SHR-1210 and SHR3162 in Patients With Advanced Solid Tumors

A Phase I, Open Label, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SHR7390 Combined With SHR-1210 and SHR3162 in Patients With Advanced Solid Tumors

A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the NCI CTCAE 4.03 for the study, the occurrence of the following drug related AEs during the single dose and the first cycle(35-38 days,two-drug combination) or the first cycle (28 days, three-drug combination) will be considered a DLT by the investigator and SMC.

MTD is the highest dose of SHR7390 in subjects with DLT less than 33.3% during the DLT observation in the dose escalation of two-drug combination.

Assessment of the incidence and severity of treatment-related AEs in all subjects who received at least 1 dose of SHR7390,SHR-1210 and SHR3162.

Pharmacokinetics profile of SHR7390:Time to peak (Tmax) of plasma concentration

Pharmacokinetics profile of SHR7390: Maximum plasma concentration (Cmax)

Pharmacokinetics profile of SHR7390: Halflife (T1/2)

Pharmacokinetics profile of SHR7390: Clearance/ bioavailability (CL/F)

Pharmacokinetics profile of SHR7390: apparent volume of distribution/bioavailability (Vd/F)

Pharmacokinetics profile of SHR7390: Area under curve (AUC)

Pharmacokinetics profile of SHR7390: Accumulation index (Rac)

Pharmacokinetics profile of SHR7390:blood concentration

Pharmacokinetics profile of SHR7390:plasma concentration

Pharmacokinetics profile of SHR3162: plasma concentration

Pharmacokinetics profile of SHR-1210: serum concentration

Subjects will be assessed using RECIST v1.1. The primary aim is to demonstrate clinically meaningful improvement in ORR.

When the dose escalation is accomplished, RP2D will be identified by the characterization of safety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC	NCT04108247	Prostate Cancer...	Abiraterone+SHR...	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 I Trial of SHR3162 in Subjects With Advanced Solid Tumors	NCT02759666	Neoplasm Solid Tumors	SHR3162	18 Years -	Atridia Pty 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
The Study of SHR7390 in Combination With SHR-1210 and SHR3162 in Patients With Advanced Solid Tumors	NCT03182673	Solid Tumor	SHR7390 SHR-1210 SHR3162	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
The Study of SHR7390 in Combination With SHR-1210 and SHR3162 in Patients With Advanced Solid Tumors	NCT03182673	Solid Tumor	SHR7390 SHR-1210 SHR3162	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for shr3162

Every month we try and update this database with for shr3162 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 shr3162

Every month we try and update this database with for shr3162 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 shr3162 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.