Status:
COMPLETED
BR101801 in Adult Patients With Advanced Hematologic Malignancies(Phase I)
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia, Phase Ib). The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerabi...
Detailed Description
1. Phase Ia (Dose Escalation) Primary Objectives * To assess the safety and tolerability of BR101801 in patients with relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL. * To assess DLT ...
Eligibility Criteria
Inclusion
- \<Inclusion Criteria\>
- Patients must sign an informed consent document
- Female or male patients aged ≥ 18 years.
- ECOG performance status ≤ 2.
- Life expectancy more than 3 months.
- Phase Ia:Patients with relapsed and/or refractory relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL diagnosed with World Health Organization (WHO) classification
- Phase Ib: Subjects with PTCL NOS, PTCL AITL, Nodal PTCL with TFH and PTCL FTCL.
- Patients have measurable disease based on the appropriate tumor type criteria( Phase Ib only)
- Have a current need for systemic therapy, the assessment of the investigator.
- An archival or fresh tumor tissue (ie, tissue block or series of at least 5 slides, up to 15 slides) is required and should be provided during the Screening Visit for Lymphoma subjects. Local review of pathology is required for study entry in Phase Ib only.
- Phase Ia subjects should be prepared to undergo a fresh tumor biopsy during the study (tumor biopsies will be obtained from 1 to 2 subjects per cohort in Phase Ia).
- Subject having laboratory values defined as:
- Creatinine clearance (measured or calculated per institutional standard practice) ≥ 60 mL/min. GFR can also be used in place of creatinine clearance.
- Total bilirubin \< 1.5 × ULN, except for subjects with Gilbert's syndrome who are excluded if total bilirubin \> 3.0 × ULN or direct bilirubin \< 1.5 × ULN.
- ALT \< 2.5 × ULN, except for subjects who have tumor involvement of the liver, who are included if ALT \< 5 × ULN.
- AST \< 2.5 × ULN, except for subjects that have tumor involvement of the liver, who are included if AST \< 5 × ULN.
- Absolute neutrophil count \> 1.0 × 109/L.
- Platelet count \> 75 × 109/L.
- Hemoglobin \> 8 g/dL.
- \<Exclusion Criteria\>
- Presence of overt leptomeningeal or active CNS metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks. Patients with treated brain metastases should be neurologically stable and off steroids for at least 2 weeks before administration of any study treatment.
- Impaired cardiac function or clinically significant cardiac disease
- Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
- Human immunodeficiency virus (HIV) infection.
- Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCVAb).
- Chronic liver disease or chronic hepatitis
- Any gastrointestinal disorders interfering with study drug absorption or are unable to swallow tablets or capsules.
- Malignant disease, other than that being treated in this study.
- Prior PI3K inhibitor will be accepted in the dose escalation part of the study (Phase Ia) only.
- For patients with lymphoma:
- Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon \[INF\], and toxin immunoconjugates) or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment.
- Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
- Unconjugated monoclonal antibody therapies \< 6 weeks before the first dose of study treatment.
- Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (≥ 10 mg/day prednisone or equivalent).
- Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
- Use of hematopoietic colony-stimulating growth factors, thrombopoietin mimetics, or erythroid-stimulating agents ≤ 2 weeks prior to start of study drug.
- 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.
- Active infection requiring systemic or antiviral antibiotic therapy.
- Subjects with active CMV infection.
- Subjects receiving moderate or potent CYP3A4 inhibitors or inducers and are unable to withdraw until 2 weeks or 5 times longer than the half-life, whichever is shorter, before the first dose of study treatment.
- Major surgery within 2 weeks of the first dose of study treatment (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
- Radiotherapy within 2 weeks of the first dose of study treatment, except for palliative radiotherapy to a limited-field, such as for the treatment of bone pain or a focally painful tumor mass.
- Presence of CTCAE ≥ Grade 2 toxicity (except alopecia, peripheral neuropathy, and ototoxicity, which are excluded if ≥ CTCAE Grade 3) due to prior cancer therapy.
- Participation in an interventional, investigational study within 2 weeks or 5 half-lives, whichever is shorter, of the first dose of study treatment.
- Any medical condition that would, in the Investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results.
- Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test.
Exclusion
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04018248
Start Date
April 21 2020
End Date
September 21 2023
Last Update
September 10 2025
Active Locations (9)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
3
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
4
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea