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NCT Number: NCT05294731

Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts

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Key information

Conditions

B-cell Malignancy Blood Protein Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma DLBCL Unclassifiable Disease Attributes Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Richter's Transformation Vascular Diseases Waldenstrom Macroglobulinemia Waldenström Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • Provision of signed and dated written informed consent prior to any study
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  • Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria
  • Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL
  • Phase 2: Confirmed diagnosis of MCL, or CLL/SLL
  • Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug

Key Exclusion Criteria

  • Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
  • Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment
  • Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.
  • Current or history of central nervous involvement
  • Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BGB-16673

Drug

Orally administered

Primary outcomes

  1. Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Time frame: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)

    Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria.

  2. Phase 1: Recommended Phase 2 dose (RP2D) of BGB-16673

    Time frame: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)

    As determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, pharmacokinetics, and pharmacodynamics data.

  3. Phase 1a: Maximum tolerated dose (MTD) of BGB-16673

    Time frame: From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)

    The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD).

  4. Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)

    Time frame: Up to approximately 3 years

    ORR is defined as the percentage of participants with partial response or better according to the Independent Review Committee (IRC) assessment and as determined by Lugano criteria.

  5. Phase 2: ORR in participants with R/R Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

    Time frame: Up to approximately 3 years

    ORR is defined as the percentage of participants with partial response or better as assessed by the IRC and determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL and by Lugano criteria for SLL

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) After a Single Dose of BGB-16673

    Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

  2. Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of BGB-16673

    Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

  3. Minimum observed plasma concentration (Cmin) After a Single Dose of BGB-16673

    Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

  4. Apparent terminal elimination half-life (t1/2) After a Single Dose of BGB-16673

    Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

  5. Area under the plasma-concentration curve (AUC) After a Single Dose of BGB-16673

    Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

  6. Apparent oral clearance (CL/F) After a Single Dose of BGB-16673

    Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

  7. Apparent volume of distribution (Vz/F) After a Single Dose of BGB-16673

    Time frame: Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

  8. Maximum observed steady state plasma concentration (Css,max) of of BGB-16673

    Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose

  9. Time to reach maximum observed steady state plasma concentration (Tss,max) of BGB-16673

    Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose

  10. Minimum observed steady state plasma concentration (Css,min) of BGB-16673

    Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose

  11. Steady state area under the plasma concentration-time curve (AUC) of BGB-16673

    Time frame: Phase 1a and Phase 2: Week 5 Day 1 pre-dose and up to 8 hours post-dose; Phase 1b: Week 5 Day 1 pre-dose and up to 6 hours post-dose

  12. Accumulation ratios of Cmax and AUC of BGB-16673

    Time frame: Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose up to 8 hours post-dose; Phase 1b: Week 1 and Week 5 pre-dose up to 6 hours post-dose; Phase 2: Week 1 and Week 5 pre-dose up to 8 hours post-dose

  13. Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy

    Time frame: Phase 1a: Day 1 pre-dose up to 72 hours post-dose, Week 5 pre-dose and 8 hours post-dose, Week 9 pre-dose; Phase 1b: Week 1 and Week 5 pre-dose and 6 hours post-dose, Week 9 pre-dose; Phase 2: Week 1, Week 5, Week 9 pre-dose

  14. Phase 1: Overall Response Rate (ORR)

    Time frame: Up to approximately 3 years

    ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL), Owen, and Lugano criteria.

  15. Phase 1: Major Response Rate (MRR) in participants with Waldenstrom macroglobulinemia (WM)

    Time frame: Up to approximately 3 years

    MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), and partial response (PR), as assessed by investigators for participants with WM only.

  16. Phase 2: Number of participants with AEs and SAEs

    Time frame: From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)

    Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0).

  17. Phase 2: ORR in participants with R/R MCL as assessed by investigators

    Time frame: Up to approximately 3 years

    ORR is defined as the percentage of participants with partial response or better according to investigators and as determined by Lugano criteria.

  18. Phase 2: Duration of Response (DOR)

    Time frame: Up to approximately 3 years

    DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by IRC and by investigators.

  19. Phase 2: Time to Response (TTR)

    Time frame: Up to approximately 3 years

    TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better) as determined by IRC and by investigators.

  20. Phase 2: Progression Free Survival (PFS)

    Time frame: Up to approximately 3 years

    PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as determined by IRC and by investigators.

  21. Phase 2: Overall Survival (OS)

    Time frame: Up to approximately 3 years

    OS is defined as the time from first study drug administration to the date of death due to any cause.

  22. Phase 2: Best Overall Response (BOR) of Partial Response with Lymphocytosis (PR-L) in Participants with R/R CLL/SLL

    Time frame: Up to approximately 3 years

    BOR of PR-L or better as determined by IRC and by investigators per iwCLL criteria for CLL and per Lugano criteria for SLL

  23. Phase 2: Change from baseline in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) Disease-related Symptom Physical and Treatment Side Effect Subscales in participants with R/R MCL

    Time frame: Baseline and Day 1 of weeks 5, 13, 25, and 37

    The NFLymSI-18 questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. A mixed model for repeated measures (MMRM) will be used to estimate the mean change from baseline for NFlymSI-18 subscales of Disease-Related Symptoms Physical (DRSP), and "treatment side effects" (TSE).

  24. Phase 2: ORR assessed by the Investigator in participants with R/R CLL/SLL

    Time frame: Up to approximately 3 years

    ORR is defined as the percentage of participants with partial response or better as determined by investigators per iwCLL criteria for CLL and Lugano criteria for SLL.

  25. Phase 2: Mean change from baseline for the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu ) questionnaire Physical Well-being and Functional Well-being Subscales for participants with R/R CLL/SLL

    Time frame: Baseline and Day 1 of weeks 5, 13, 25, and 37

    FACT-Leu is a 44-item patient reported outcome questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients. Each question is scored from 0 (not at all) to 4 (very much).

Study contacts

Contact information is provided by the study sponsor or research team.

BeiGene

CONTACT

[email protected]

1.877.828.5568

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Mar 24, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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