This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia and Phase Ib).
The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RDE) of BR101801 in patients with relapsed/refractory advanced hematologic malignancies except acute leukemia and multiple myeloma.
The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory hematologic malignances at a dose of BR101801 identified in Phase Ia.
Condition or disease | Intervention/treatment | Phase |
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Diffuse Large B Cell Lymphoma Follicular Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Leukemia B Cell Lymphoma Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Peripheral T Cell Lymphoma | Drug: BR101801 (Phase Ia) Drug: BR101801 (Phase Ib) | Phase 1 |
Phase Ia (Dose Escalation)
Primary Objectives
SecondaryObjectives
Primary Objectives
•To assess the safety and tolerability of BR101801 at the RDE dose in patients with relapsed and/or refractory B-cell lymphoma, CLL/SLL, and PTCL.
SecondaryObjectives
OUTLINE: This is a Phase I, multi-center, open-label, FIH study. Safety monitoring committee (SMC) will be responsible for safety oversight.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Open-label, Multi-center, Dose Escalation, and Expansion Study of BR101801 in Adult Patients With Advanced Hematologic Malignancies |
Actual Study Start Date : | April 21, 2020 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | February 2024 |
Arm | Intervention/treatment |
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Experimental: Treatment ( BR101801):Phase Ia (dose escalation)
Patients will receive BR101801 capsules orally, QD in 28-day cycles. The regimen may be changed to BID dosing based on emerging data.
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Drug: BR101801 (Phase Ia)
Phase Ia (dose escalation):25 mg capsules and 100 mg capsules Planned doses are 50, 100, 200, 325, and 450 mg.
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Experimental: Treatment ( BR101801):Phase Ib (dose expansion)
Group A: Patients with diffuse large B-cell lymphoma (DLBCL) including MYC-altered DLBCL Group B: Patients with follicular lymphoma. Group C: Patients with chronic lymphocytic leukemia/small lymphocytic leukemia, other B-cell lymphoma such as, but not limited to mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or PTCL |
Drug: BR101801 (Phase Ib)
Phase Ib (dose expansion):25 and 100 mg capsules Doses administered will be determined from Phase Ia data.
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To evaluate safety and tolerability the aggregate review will include but is not limited to:
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
<Inclusion Criteria>
Phase Ib:
<Exclusion Criteria>
For patients with lymphoma:
11.Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10 mg/day prednisone or equivalent).
12.Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
13.Use of hematopoietic colony-stimulating growth factors, thrombopoietin mimetics, or erythroid-stimulating agents ≤ 2 weeks prior to start of study drug.
14.Patients with a history of stroke or having active neurological symptoms, with the exception of chronic conditions which, in the opinion of the neurologist, Investigator, and the Sponsor, would not impact ongoing neurologic assessments while on study treatment.
15.Active infection requiring systemic or antiviral antibiotic therapy. 16.Major surgery within 2 weeks of the first dose of study treatment 17.Radiotherapy within 2 weeks of the first dose of study drug, except for palliative radiotherapy to a limited-field, such as for the treatment of bone pain or a focally painful tumor mass.
18.Presence of CTCAE ≥ Grade 2 toxicity due to prior cancer therapy. 19.Participation in an interventional, investigational study within 2 weeks or 5 half-lives, whichever is shorter, of the first dose of study treatment.
20.Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results.
Contact: Jayhyuk Myung | +82-31-491-2271 (Ext. 501) | jhmyung@boryung.co.kr | |
Contact: Bong-Seog Kim | +8227088095 | seog9270@boryung.co.kr |
Korea, Republic of | |
Asan Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: DH Yoon, MD, PhD | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: SJ Kim, MD, PhD | |
Seoul national university hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: TM Kim, MD, PhD |
Principal Investigator: | TM Kim, M.D, Ph.D | Seoul National University Hospital | |
Principal Investigator: | SJ Kim, M.D, Ph.D | Samsung Medical Center | |
Principal Investigator: | DH Yoon, M.D, Ph.D | Asan Medical Center | |
Principal Investigator: | Jorge Chaves, M.D, Ph.D | Northwest Medical Specialities, PLLC | |
Principal Investigator: | Emily Curran, M.D, Ph.D | University of Cincinnati |
Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | June 14, 2019 | |||||||||||||||
First Posted Date ICMJE | July 12, 2019 | |||||||||||||||
Last Update Posted Date | July 1, 2020 | |||||||||||||||
Actual Study Start Date ICMJE | April 21, 2020 | |||||||||||||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I) | |||||||||||||||
Official Title ICMJE | A Phase I, Open-label, Multi-center, Dose Escalation, and Expansion Study of BR101801 in Adult Patients With Advanced Hematologic Malignancies | |||||||||||||||
Brief Summary |
This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia and Phase Ib). The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RDE) of BR101801 in patients with relapsed/refractory advanced hematologic malignancies except acute leukemia and multiple myeloma. The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory hematologic malignances at a dose of BR101801 identified in Phase Ia. |
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Detailed Description |
Primary Objectives •To assess the safety and tolerability of BR101801 at the RDE dose in patients with relapsed and/or refractory B-cell lymphoma, CLL/SLL, and PTCL. SecondaryObjectives
OUTLINE: This is a Phase I, multi-center, open-label, FIH study. Safety monitoring committee (SMC) will be responsible for safety oversight. |
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 1 | |||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Recruiting | |||||||||||||||
Estimated Enrollment ICMJE |
90 | |||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||
Estimated Study Completion Date ICMJE | February 2024 | |||||||||||||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE |
<Inclusion Criteria>
<Exclusion Criteria>
11.Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10 mg/day prednisone or equivalent). 12.Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment. 13.Use of hematopoietic colony-stimulating growth factors, thrombopoietin mimetics, or erythroid-stimulating agents ≤ 2 weeks prior to start of study drug. 14.Patients with a history of stroke or having active neurological symptoms, with the exception of chronic conditions which, in the opinion of the neurologist, Investigator, and the Sponsor, would not impact ongoing neurologic assessments while on study treatment. 15.Active infection requiring systemic or antiviral antibiotic therapy. 16.Major surgery within 2 weeks of the first dose of study treatment 17.Radiotherapy within 2 weeks of the first dose of study drug, except for palliative radiotherapy to a limited-field, such as for the treatment of bone pain or a focally painful tumor mass. 18.Presence of CTCAE ≥ Grade 2 toxicity due to prior cancer therapy. 19.Participation in an interventional, investigational study within 2 weeks or 5 half-lives, whichever is shorter, of the first dose of study treatment. 20.Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Korea, Republic of | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT04018248 | |||||||||||||||
Other Study ID Numbers ICMJE | BR-101801-CT-101 | |||||||||||||||
Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Boryung Pharmaceutical Co., Ltd | |||||||||||||||
Study Sponsor ICMJE | Boryung Pharmaceutical Co., Ltd | |||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||
Investigators ICMJE |
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PRS Account | Boryung Pharmaceutical Co., Ltd | |||||||||||||||
Verification Date | June 2020 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |