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A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

PHASE1PHASE2RECRUITING

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.

Study details:

This new study will check how safe and helpful a potential anticancer drug called BGB-16673 is in participants with R/R B-cell malignancies when it is given in combination with other medicines - sonrotoclax in substudy 1, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4. Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF
  2. Confirmed diagnosis of a R/R B-cell malignancy
  3. Protocol-defined measurable disease
  4. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
  5. Adequate organ function
  6. Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
  7. Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab
  8. Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min (Substudies 1, 3, and 4)
  9. Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression (Substudy 2)
  10. Adequate renal function as indicated by eGFR of ≥ 30 mL/min (Substudy 2)

Exclusion criteria

  1. Treatment-naive B-cell malignancies
  2. Unable to comply with the requirements of the protocol
  3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  4. Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively
  5. Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
  6. Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent (Substudies 1 and 2)
  7. Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab
  8. Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen) (Substudy 1)
  9. Participants who discontinued prior zanubrutinib treatment due to intolerance (Substudy 2)
  10. Prior exposure to a CD20 x CD3 T-cell engager antibody treatment (Substudies 3 and 4)
  11. All participants with a prior allogeneic stem cell transplant (Substudies 3 and 4)

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study ID

NCT06634589

Intervention or treatment

DRUG: BGB-16673

DRUG: Sonrotoclax

DRUG: Zanubrutinib

DRUG: Mosunetuzumab

DRUG: Glofitamab

DRUG: Obinutuzumab

Conditions

  • B-cell Malignancy
  • Relapsed Cancer
  • Refractory Cancer
  • B-cell Lymphoma

  • Condition: B-cell Malignancy, Relapsed Cancer and more

  • DRUG: BGB-16673 and other drugs

  • Kogarah, New South Wales, Australia and more

  • Sponsor: BeiGene

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

St George Hospital

Select from list below to view details:

  • St George Hospital

    Kogarah, New South Wales, Australia

  • Mater Cancer Care Centre

    South Brisbane, Queensland, Australia

  • Monash Health

    Clayton, Victoria, Australia

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

B

BeiGene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Substudy 1 Part 1a: Dose Escalation
  • Sequential cohorts of increasing dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Drug: Tacabrutideg, Drug: Sonrotoclax
    EXPERIMENTAL: Substudy 1 Part 1b: Safety Expansion
    • Cohorts of select dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
    Drug: Tacabrutideg, Drug: Sonrotoclax
      EXPERIMENTAL: Substudy 2 Part 1a: Dose Escalation
      • Sequential cohorts of increasing dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
      Drug: Tacabrutideg, Drug: Zanubrutinib
        EXPERIMENTAL: Substudy 2 Part 1b: Safety Expansion
        • Cohorts of select dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
        Drug: Tacabrutideg, Drug: Zanubrutinib
          EXPERIMENTAL: Substudy 3 Part 1a: Dose Escalation
          • Sequential cohorts of increasing dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
          Drug: Tacabrutideg, Drug: Mosunetuzumab
            EXPERIMENTAL: Substudy 3 Part 1b: Safety Expansion
            • Cohorts of select dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
            Drug: Tacabrutideg, Drug: Mosunetuzumab
              EXPERIMENTAL: Substudy 4 Part 1a: Dose Escalation
              • Sequential cohorts of increasing dose level combinations of tacabrutideg and glofitamab will be evaluated in participants with selected B-cell malignancies. Participants will receive obinutuzumab as pretreatment prior to the start of combination treatment.
              Drug: Tacabrutideg, Drug: Glofitamab, Drug: Obinutuzumab
                EXPERIMENTAL: Substudy 4 Part 1b: Safety Expansion
                • Cohorts of select dose level combinations of tacabrutideg and glofitamab will be evaluated in participants with selected B-cell malignancies.
                Drug: Tacabrutideg, Drug: Glofitamab, Drug: Obinutuzumab

                  What is the study measuring?

                  Primary Outcome

                  MeasureDescriptionTime Frame
                  Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
                  Substudy 1 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
                  Substudy 2 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
                  Substudy 2 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
                  Substudy 3 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
                  Substudy 3 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years]
                  Substudy 4 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
                  Substudy 4 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse eventsNot SpecifiedFrom the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years

                  Secondary Outcome

                  MeasureDescriptionTime Frame
                  Substudy 1 Parts 1a and 1b: Overall Response Rate (ORR) in participants with B-cell malignanciesORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by investigator.Up to approximately 3 years
                  Substudy 1 Parts 1a and 1b: Duration of Response (DOR)DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.Up to approximately 3 years
                  Substudy 1 Parts 1a and 1b: Time to Response (TTR)TTR is defined as the time from treatment initiation to first documented response.Up to approximately 3 years
                  Substudy 1 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673 and sonrotoclaxNot SpecifiedFrom Week 1 to Week 17
                  Substudy 1 Part 1a: Maximum observed concentration (Cmax) of BGB-16673 and sonrotoclaxNot SpecifiedFrom Week 1 to Week 17
                  Substudy 1 Part 1a: Time to maximum concentration (Tmax) of BGB-16673 and sonrotoclaxNot SpecifiedFrom Week 1 to Week 17
                  Substudy 1 Part 1a: Terminal half-life (t1/2) of BGB-16673 and sonrotoclaxNot SpecifiedFrom Week 1 to Week 17
                  Substudy 1 Parts 1a and 1b: Trough concentration (Ctrough) of BGB-16673 and sonrotoclaxNot SpecifiedFrom Week 1 to Week 17
                  Substudy 1 Part 1b: Number of patients with complete response or complete response with incomplete count recovery (CR/CRi) who achieve undetectable minimal residual disease (uMRD)Not SpecifiedUp to approximately 3 years
                  Substudy 2 Parts 1a and 1b: ORR in participants with B-cell malignanciesORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator.Up to approximately 3 years
                  Substudy 2 Parts 1a and 1b: DORDOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.Up to approximately 3 years
                  Substudy 2 Parts 1a and 1b: TTRTTR is defined as the time from treatment initiation to the first documented response.Up to approximately 3 years
                  Substudy 2 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673 and zanubrutinibNot SpecifiedFrom Week 1 to Week 17
                  Substudy 2 Part 1a: Maximum observed concentration (Cmax) of BGB-16673 and zanubrutinibNot SpecifiedFrom Week 1 to Week 17
                  Substudy 2 Part 1a: Time to maximum concentration (Tmax) of BGB-16673 and zanubrutinibNot SpecifiedFrom Week 1 to Week 17
                  Substudy 2 Part 1a: Terminal half-life (t1/2) of BGB-16673 and zanubrutinibNot SpecifiedFrom Week 1 to Week 17
                  Substudy 2 Parts 1a and 1b: Trough concentration (Ctrough) of BGB-16673 and zanubrutinibNot SpecifiedFrom Week 1 to Week 17 for Part 1a; From Week 1 to Week 5 for Part 1b
                  Substudy 3 Parts 1a and 1b: ORR in participants with B-cell malignanciesORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator.Up to approximately 3 years
                  Substudy 3 Parts 1a and 1b: DORDOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.Up to approximately 3 years
                  Substudy 3 Parts 1a and 1b: TTRTTR is defined as the time from treatment initiation to the first documented response.Up to approximately 3 years
                  Substudy 3 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673 and mosunetuzumabNot SpecifiedFrom Week 1 to Week 12
                  Substudy 3 Part 1a: Maximum observed concentration (Cmax) of BGB-16673 and mosunetuzumabNot SpecifiedFrom Week 1 to Week 12
                  Substudy 3 Part 1a: Time to maximum concentration (Tmax) of BGB-16673 and mosunetuzumabNot SpecifiedFrom Week 1 to Week 12
                  Substudy 3 Part 1a: Terminal half-life (t1/2) of BGB-16673 and mosunetuzumabNot SpecifiedFrom Week 1 to Week 12
                  Substudy 3 Parts 1a and 1b: Trough concentration (Ctrough) of BGB-16673 and mosunetuzumabNot SpecifiedFrom Week 1 to Week 36
                  Substudy 4 Parts 1a and 1b: ORR in participants with B-cell malignanciesORR is defined as the percentage of participants with partial response (PR) or better as assessed by the investigator.Up to approximately 3 years
                  Substudy 4 Parts 1a and 1b: DORDOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.Up to approximately 3 years
                  Substudy 4 Parts 1a and 1b: TTRTTR is defined as the time from treatment initiation to the first documented response.Up to approximately 3 years
                  Substudy 4 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673Not SpecifiedFrom Week 1 to Week 10
                  Substudy 4 Part 1a: Maximum observed concentration (Cmax) of BGB-16673Not SpecifiedFrom Week 1 to Week 10
                  Substudy 4 Part 1a: Time to maximum concentration (Tmax) of BGB-16673Not SpecifiedFrom Week 1 to Week 10
                  Substudy 4 Part 1a: Terminal half-life (t1/2) of BGB-16673Not SpecifiedFrom Week 1 to Week 10
                  Substudy 4 Parts 1a and 1b: Trough concentration (Ctrough) of BGB-16673Not SpecifiedFrom Week 1 to Week 10
                  Are you running this trial?If you're a clinic or sponsor, you can claim this study.
                  Claim this trial

                  References

                  Clinical Trials Gov: A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

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