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Trial Title:
Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers
NCT ID:
NCT05749549
Condition:
Advanced Cancer
Follicular Lymphoma
Peripheral T Cell Lymphoma
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell, Peripheral
Lymphoma, Large B-Cell, Diffuse
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BR1733
Description:
Subjects will receive oral administration of BR1733.
Arm group label:
BR1733
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign informed consent voluntarily.
2. Subjects with PTCL, DLBCL or advance solid tumors diagnosed by histology or
cytology，whose disease progressed after standard treatment or have no standard
treatment.
3. ECOG≤2.
4. Expected survival period ≥ 3 months.
5. Adequate organ function reserve at baseline.
Exclusion Criteria:
1. Subjects with symptomatic central nervous system (CNS) metastases or carcinomatous
meningitis;
2. Subjects with a history of other primary malignancies within 5 years (except for
cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder
tumor), subjects with other primary tumors who had no evidence of disease for 5
years or more and did not require treatment could participate in the study;
3. Subjects with any severe uncontrolled disease such as liver disease such as
cirrhosis, decompensated liver disease, kidney failure needs for hemodialysis or
peritoneal dialysis, etc.
4. Subjects with HIV disease or a positive HIV test; or active hepatitis.
5. Subjects with organ transplantation (apart from keratoplasty) or allogeneic
hematopoietic stem cell transplantation.
6. Subjects with impaired or clinically significant cardiac cerebrovascular disease.
7. Subjects known to be allergic to experimental drugs or similar compounds.
8. Subjects known with psychotropic substance abuse, alcohol or drug abuse, or mental
disorders.
9. Any previous treatment with other EED inhibitors (e.g., MAK683, FTX-6058, etc.).
10. Females who are pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Address:
City:
Tianjin
Country:
China
Start date:
April 19, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Shanghai Blueray Biopharma Co., Ltd.
Agency class:
Industry
Source:
Shanghai Blueray Biopharma Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05749549
