Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Subjects will receive oral administration of BR1733.

BR1733

This study is a Phase I/IIa, multi-center, open-label study of BR1733 with a dose escalation part followed by a dose expansion part in adult subjects with advanced cancers.

This treatment to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.

The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

This is a multi-center, nonrandomized, open-label study to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics, and efficacy of BR1733 in patients with advance cancer, such as recurrent/refractory follicular lymphoma, peripheral T cell lymphoma(PTCL), diffuse large B cell lymphoma(DLBCL) and advance solid tumors.

Phase Ⅰ (Dose Escalation Phase): According to the incidence of DLT in BR1733 tablets in the treatment of advanced cancers, MTD and the Phase 2 clinical trial dose (RP2D) combining PK, PD, efficacy and safety data were determined.

Phase IIa (Dose expansion stage): Evaluate the efficacy and safety of BR1733 monotherapy (Cohorts 1-5) in five separate cohorts.

Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers

A Multicenter, Open-Label Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics and Efficacy of BR1733 Monotherapy in Subjects With Advanced Cancers

To assess adverse events as dose limiting toxicities as defined by the protocol.

The proportion of patients with a best response of at least partial remission (including partial remission and complete remission) using disease appropriate standardized response criteria.

Pharmacokinetics profile of BR1733 (plasma): Halflife (T1/2)

Pharmacokinetics profile of BR1733 (plasma): Area under curve (AUC)

Pharmacokinetics profile of BR1733 (plasma): Maximum plasma concentration (Cmax)

Pharmacokinetics profile of continuous medication of BR1733 (plasma): Area under curve, steady state (AUCss)

Pharmacokinetics profile of continuous medication of BR1733 (plasma):

Maximum plasma concentration, steady state (Cmax,ss)

Pharmacokinetics profile of BR1733 (plasma): Clearance/bioavailability (CL/F)

Adverse events assessed according to NCI-CTCAE v5.0 criteria.

DoR is defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.

OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers	NCT05749549	Advanced Cancer Follicular Lymp... Peripheral T Ce... Diffuse Large B...	BR1733	18 Years -	Shanghai Blueray Biopharma Co., Ltd.
Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers	NCT05749549	Advanced Cancer Follicular Lymp... Peripheral T Ce... Diffuse Large B...	BR1733	18 Years -	Shanghai Blueray Biopharma Co., Ltd.

Spots Global Cancer Trial Database for br1733

Every month we try and update this database with for br1733 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 br1733

Every month we try and update this database with for br1733 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 br1733 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.