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Recruiting Phase 1/2

A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies

NCT05006716 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 1/2
Started
2021-09-13
Last updated
2026-10-05

Condition(s) studied

B-cell MalignancyMarginal Zone LymphomaFollicular LymphomaNon-Hodgkin LymphomaWaldenström MacroglobulinemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMantle Cell LymphomaDiffuse Large B Cell LymphomaRichter Transformation

Investigational drug(s) / intervention(s)

Tacabrutideg →

Tacabrutideg: Orally administered

Study summary

Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria : 1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL. 2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance). 3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance. 4. Measurable disease by radiographic assessment or serum IgM level (WM only) 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 6. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2). Exclusion Criteria: 1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur. 2. Requires ongoing systemic treatment for any other malignancy 3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment. 4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease 5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • Phase 1: Number of Participants with Adverse Events (AEs) — From the first dose of tacabrutideg until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
    Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
  • Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Tacabrutideg — Approximately 28 days
    MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached.
  • Phase 1: Recommended dose(s) for Expansion (RDFE) of tacabrutideg — Approximately 3 years
    RDFE of tacabrutideg alone will be determined based upon the MTD or MAD.
  • Phase 2: Overall response rate (ORR) — approximately 3 years
    Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R/R CLL/SLL and R/R WM (in participants with WM, this is also referred to as major response rate) and by the investigator for other cohorts (R/R MCL, R/R MZL, R/R FL, R/R non-GCB DLBCL, R/R Richter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, International Workshop of Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL, and the 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM-11) criteria for WM.

Trial sites (114)

FacilityCityRegionStatus
University of Alabama At Birmingham Hospital Birmingham Alabama Recruiting
Mayo Clinic Phoenix Phoenix Arizona Completed
Honor Health Research Institute Scottsdale Arizona Recruiting
University of Arizona Cancer Center Tucson Arizona Recruiting
University of California San Diego (Ucsd) Moores Cancer Center La Jolla California Recruiting
Stanford Medicine Palo Alto California Recruiting
UCLA Santa Monica Cancer Care Santa Monica California Recruiting
Uchealth North Fort Collins Colorado Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center Miami Florida Recruiting
Tampa General Hospital Cancer Institute Tampa Florida Recruiting
Augusta University Augusta Georgia Recruiting
Southeastern Regional Medical Center Newnan Georgia Recruiting
Midwestern Regional Medical Center Zion Illinois Completed
University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
Norton Cancer Institute Pavilion Louisville Kentucky Active Not Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
American Oncology Partners of Maryland Pa Bethesda Maryland Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Comprehensive Cancer Centers of Nevada Las Vegas Nevada Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
Columbia University Medical Center New York New York Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital New York New York Recruiting
Memorial Sloan Kettering Cancer Center Mskcc New York New York Recruiting
Tennesse Oncology Chattanooga Downtown Chattanooga Tennessee Recruiting
Tennessee Oncology, Pllc Nashville Nashville Tennessee Recruiting
Md Anderson Cancer Center Houston Texas Recruiting
Virginia Commonwealth University Massey Cancer Center Richmond Virginia Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington Recruiting
Concord Repatriation General Hospital Concord New South Wales Recruiting
Calvary Mater Newcastle Waratah New South Wales Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
St Vincents Hospital Melbourne Fitzroy Victoria Recruiting
Austin Health Heidelberg Victoria Recruiting
Peter Maccallum Cancer Centre Melbourne Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Linear Clinical Research Nedlands Western Australia Recruiting
Perth Blood Institute West Perth Western Australia Recruiting

+ 74 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05006716 on ClinicalTrials.gov ↗ ← All trials in Turkey