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A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies

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ClinicalTrials.gov Identifier: NCT05006716
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : May 12, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE August 9, 2021
First Posted Date  ICMJE August 16, 2021
Last Update Posted Date May 12, 2022
Actual Study Start Date  ICMJE September 13, 2021
Estimated Primary Completion Date May 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2021)
  • Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE V5. [ Time Frame: approximately 3 years ]
    also may be assessed using the 2018 iwCLL Guidelines for Diagnosis, Indications for Treatment, Response Assessment, and Supportive Management of CLLA. TEAE is defined as an AE that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of the first dose of the study drug and up to 30 days after the last dose of study treatment or the initiation of a new anticancer therapy, whichever is earlier
  • Recommended Phase 2 Dose (RP2D) of Orally Administered BGB-16673 [ Time Frame: approximately 3 years ]
    The RP2D is the maximum tolerated dose (MTD) or less. An RP2D less than the MTD may be chosen if aspects of tolerability or efficacy not encompassed by the MTD determination suggest utilizing a lower dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2021)
  • Single Dose Maximum observed plasma concentration (Cmax) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Single Dose Minimum observed plasma concentration (Cmin) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Single Dose Time to reach Cmax (tmax) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Single Dose Time to reach half of Cmax (T1/2) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Single Dose Area under the plasma concentration-time curve (AUC) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Single Dose apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Single Dose apparent volume of distribution (Vz/F) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Single Dose accumulation ratios of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Steady State Maximum observed plasma concentration (Cmax) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Steady State minimum observed plasma concentration (Cmin) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Steady State Time to reach Cmax (tmax) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Steady State Time to reach half of Cmax (T1/2) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Steady State Area under the plasma concentration-time curve (AUC) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Steady State apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • Steady State apparent volume of distribution (Vz/F) of BGB-16673 [ Time Frame: Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years) ]
    Collected for both Part 1 and Part 2
  • BTK protein degradation in peripheral blood upon BGB-16673 monotherapy [ Time Frame: Day 1 pre-dose and 8 hours post-dose (approximately 2 years) ]
  • Number of Participants with overall response rate (ORR) [ Time Frame: approximately 3 years ]
    Best overall response is defined as the best response recorded from the first dose of the study drug until data cut or the initiation of a new anticancer treatment
  • Number of WM Participants with major response rate (MRR) [ Time Frame: approximately 3 years ]
    MRR is defined as the proportion of patients whose best overall response (BOR) is partial response (PR) or better (PR, very good partial response [VGPR], or complete response (CR)).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies
Official Title  ICMJE A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies
Brief Summary Study consists of two parts to explore BGB-16673 recommended dosing, a part 1 monotherapy dose finding and a part 2 (cohort expansion in two cohorts)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B-cell Malignancy
  • Marginal Zone Lymphoma
  • Follicular Lymphoma
  • Non-hodgkin Lymphoma
  • Waldenström Macroglobulinemia
Intervention  ICMJE Drug: BGB-16673
BGB-16673 doses are to be administered as a once daily regimen
Study Arms  ICMJE
  • Experimental: Part 1 Monotherapy Dose Finding
    BGB-16673
    Intervention: Drug: BGB-16673
  • Experimental: Part 2 Expansion Cohorts
    BGB-11673 for two expansion cohorts
    Intervention: Drug: BGB-16673
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 9, 2021)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2025
Estimated Primary Completion Date May 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
  2. Age ≥ 18 years
  3. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: MZL, FL, MCL, CLL/SLL, or WM.
  4. Patients who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks.
  5. For dose-finding and dose-expansion, patients 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.
  6. Measurable disease by radiographic assessment or serum IgM level (WM only)
  7. ECOG Performance Status of 0 to 2
  8. Patients enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy; patients with CLL/SLL or MCL enrolling in the expansion cohorts must have been treated with a BTKi in a prior line of therapy.

Exclusion Criteria:

  1. 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
  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 patient 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, or

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene 1.877.828.5568 clinicaltrials@beigene.com
Contact: Study Director, MD
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05006716
Other Study ID Numbers  ICMJE BGB-16673-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BeiGene
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP