BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Criteria

1. Patients must sign an informed consent document

2. Female or male patients aged ≥ 18 years.

3. ECOG performance status ≤ 2.

4. Life expectancy more than 3 months.

5. Phase Ia:Patients with relapsed and/or refractory relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL diagnosed with World Health Organization (WHO) classification

6. Phase Ib:

• Group A: Patients with DLBCL including MYC-altered DLBCL and transformed DLBCL.

• Group B: Patients with follicular lymphoma Grade 1 to 3a

• Group C: Patients with CLL/SLL, other B-cell lymphoma such as, but not limited to, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, and PTCL

7. Patients have measurable disease based on the appropriate tumor type criteria( Phase Ib only)

1. 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.

2. Impaired cardiac function or clinically significant cardiac disease

3. Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.

4. Human immunodeficiency virus (HIV) infection.

5. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCVAb).

6. Chronic liver disease or chronic hepatitis

7. Any gastrointestinal disorders interfering with study drug absorption or are unable to swallow tablets or capsules.

8. Malignant disease, other than that being treated in this study.

9. For patients with lymphoma:

• Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment.

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.