Advanced CancerPhase 1/2NCT05749549
Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers
A Phase 1/2 study testing BR1733 in people with Advanced Cancer and Follicular Lymphoma, run by Shanghai Blueray Biopharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Follicular Lymphoma, Peripheral T Cell Lymphoma
- What is being tested?
- BR1733
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2023to May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent voluntarily.
- Subjects with PTCL, DLBCL or advance solid tumors diagnosed by histology or cytology，whose disease progressed after standard treatment or have no standard treatment.
- ECOG≤2.
- Expected survival period ≥ 3 months.
- Adequate organ function reserve at baseline.
Who cannot join
- Subjects with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis;
- 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;
- 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.
- Subjects with HIV disease or a positive HIV test; or active hepatitis.
- Subjects with organ transplantation (apart from keratoplasty) or allogeneic hematopoietic stem cell transplantation.
- Subjects with impaired or clinically significant cardiac cerebrovascular disease.
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- Subjects known to be allergic to experimental drugs or similar compounds.
- Subjects known with psychotropic substance abuse, alcohol or drug abuse, or mental disorders.
- Any previous treatment with other EED inhibitors (e.g., MAK683, FTX-6058, etc.).
- Females who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Advanced Cancer, Follicular Lymphoma, Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Being tested
- BR1733
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1733Drug
Subjects will receive oral administration of BR1733.
| Study group | Role | What they receive |
|---|---|---|
| BR1733 | Experimental | 25-1200 mg QD or BID Receives: Drug: BR1733 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT, Phase Ⅰ only)
To assess adverse events as dose limiting toxicities as defined by the protocol.
Measured: 28 day cycle of therapy
Objective Response Rate (ORR, Phase Ⅱa)
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.
Measured: 24 months
Secondary outcomes (10)
Halflife (T1/2) of BR1733 monotherapy
Pharmacokinetics profile of BR1733 (plasma): Halflife (T1/2)
Measured: 28 day cycle of therapy
Area under curve (AUC) of BR1733 monotherapy
Pharmacokinetics profile of BR1733 (plasma): Area under curve (AUC)
Measured: 28 day cycle of therapy
Maximum plasma concentration (Cmax) of BR1733 monotherapy
Pharmacokinetics profile of BR1733 (plasma): Maximum plasma concentration (Cmax)
Measured: 28 day cycle of therapy
Area under curve, steady state (AUCss) of BR1733 monotherapy
Pharmacokinetics profile of continuous medication of BR1733 (plasma): Area under curve, steady state (AUCss)
Measured: 28 day cycle of therapy
Maximum plasma concentration, steady state (Cmax,ss) of BR1733 monotherapy
Pharmacokinetics profile of continuous medication of BR1733 (plasma):
Maximum plasma concentration, steady state (Cmax,ss)
Measured: 28 day cycle of therapy
Clearance/ bioavailability (CL/F) of BR1733 monotherapy
Pharmacokinetics profile of BR1733 (plasma): Clearance/bioavailability (CL/F)
Measured: 28 day cycle of therapy
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Adverse events assessed according to NCI-CTCAE v5.0 criteria.
Measured: Up to 2 years
Duration of Response (DoR)
DoR is defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.
Measured: Up to 2 years
Overall Survival (OS)
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
Measured: Up to 2 years
Progression-free survival (PFS)
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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start19 Apr 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Blueray Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749549
- Sponsor's protocol ID
- BR1733-101
- Status last verified
- Aug 2024
- First submitted
- 16 Feb 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05749549
- Acronym / sponsor ID
- BR1733-101
- Conditions
- Advanced Cancer, Follicular Lymphoma, Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- Shanghai Blueray Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BR1733 | Experimental | Drug: BR173325-1200 mg QD or BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign informed consent voluntarily.
- Subjects with PTCL, DLBCL or advance solid tumors diagnosed by histology or cytology，whose disease progressed after standard treatment or have no standard treatment.
- ECOG≤2.
- Expected survival period ≥ 3 months.
- Adequate organ function reserve at baseline.
Key exclusion criteria (10 listed)
- Subjects with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis;
- 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;
- 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.
- Subjects with HIV disease or a positive HIV test; or active hepatitis.
- Subjects with organ transplantation (apart from keratoplasty) or allogeneic hematopoietic stem cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR1733Subjects will receive oral administration of BR1733. | Drug | BR1733 |
Primary outcome
Dose Limiting Toxicity (DLT, Phase Ⅰ only)
Time frame: 28 day cycle of therapy
To assess adverse events as dose limiting toxicities as defined by the protocol.
Objective Response Rate (ORR, Phase Ⅱa)
Time frame: 24 months
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.
10 secondary outcomes
Halflife (T1/2) of BR1733 monotherapy
Time frame: 28 day cycle of therapy
Area under curve (AUC) of BR1733 monotherapy
Time frame: 28 day cycle of therapy
Maximum plasma concentration (Cmax) of BR1733 monotherapy
Time frame: 28 day cycle of therapy
Area under curve, steady state (AUCss) of BR1733 monotherapy
Time frame: 28 day cycle of therapy
Maximum plasma concentration, steady state (Cmax,ss) of BR1733 monotherapy
Time frame: 28 day cycle of therapy
Clearance/ bioavailability (CL/F) of BR1733 monotherapy
Time frame: 28 day cycle of therapy
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BR1733 in people with Advanced Cancer and Follicular Lymphoma, run by Shanghai Blueray Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT, Phase Ⅰ only) (time frame: 28 day cycle of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.