Clinical Trials List
Protocol NumberM23-324
NCT Number(ClinicalTrials.gov Identfier)NCT05618028
Active
2025-10-01 - 2030-12-31
Phase I
Recruiting3
A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
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Trial Applicant
AbbVie
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 鄭富銘 Division of Hematology & Oncology
- 王幸婷 Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Wei-Ching Lin Division of Radiology
- 陳珈妤 Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Huai-Hsuan Huang Division of General Internal Medicine
- Wen-Chien Chou Division of Others -
- - - Division of General Internal Medicine
- 田豐銘 Division of General Internal Medicine
- MING YAO Division of General Internal Medicine
- 李思慧 Division of Family Medicine
- Shang-Ju Wu Division of General Internal Medicine
- Chien-Chin Lin Division of Others -
- 林明恩 Division of General Internal Medicine
- HSIN-AN HOU Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Diffuse Large B-Cell Lymphoma、 Chronic Lymphocytic Leukemia 、B Cell Malignancies 、Non-Hodgkin's Lymphoma
Objectives
Main objectives:
• Describe the safety, tolerability, and pharmacokinetics (PK) of ABBV-525 as monotherapy and in combination with ibrutinib for the treatment of R/R B cell NHL.
• Determine the RP2D of ABBV-525 monotherapy and the RP1ED of ABBV-525 in combination with ibrutinib.
Test Drug
lozenges
Active Ingredient
ABBV-525
Dosage Form
110
Dosage
ＮＡ
Endpoints
• Safety indicators will be assessed based on, but not limited to, DLT, TLS, AE, SAE, clinical laboratory parameters (hematology and biochemistry), vital sign measurements, and ECG variables.
• PK parameters (including Cmax, Tmax, and AUC) for ABBV-525 and ibrutinib will be determined using non-compartmental methods.
• PK parameters (including Cmax, Tmax, and AUC) for ABBV-525 and ibrutinib will be determined using non-compartmental methods.
Inclution Criteria
Inclusion Criteria:
Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol.
Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, with measurable disease requiring treatment.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
Participant has a life expectancy >= 12 weeks.
Adequate hematological and hepatic function as defined in the protocol.
Must have archival or freshly collected tumor tissue for correlative studies before study enrollment.
Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible.
Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.
Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol.
Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, with measurable disease requiring treatment.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
Participant has a life expectancy >= 12 weeks.
Adequate hematological and hepatic function as defined in the protocol.
Must have archival or freshly collected tumor tissue for correlative studies before study enrollment.
Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible.
Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.
Exclusion Criteria
Exclusion Criteria:
Known active CNS disease, or primary CNS lymphoma.
Known bleeding disorders.
Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
Uncontrolled active systemic infection, or active cytomegalovirus infection.
Active and/or chronic hepatitis B or C infection and/or the criteria listed in the protocol.
Known history of human immunodeficiency virus (HIV).
Known active COVID-19 infection. Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (e.g., polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.
Known active CNS disease, or primary CNS lymphoma.
Known bleeding disorders.
Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
Uncontrolled active systemic infection, or active cytomegalovirus infection.
Active and/or chronic hepatitis B or C infection and/or the criteria listed in the protocol.
Known history of human immunodeficiency virus (HIV).
Known active COVID-19 infection. Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (e.g., polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
250 participants
