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

ConditionsB-cell MalignancyRelapsed CancerRefractory CancerB-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with tacabrutideg 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Confirmed diagnosis of a R/R B-cell malignancy

Protocol-defined measurable disease

Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

Disqualifiers

Treatment-naive B-cell malignancies

Unable to comply with the requirements of the protocol

Active leptomeningeal disease or uncontrolled, untreated brain metastasis

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tacabrutideg

    Drug

    Administered orally

  • Sonrotoclax

    Drug

    Administered orally

  • Zanubrutinib

    Drug

    Administered orally

  • Mosunetuzumab

    Drug

    Administered subcutaneously

  • Glofitamab

    Drug

    Administered intravenously

  • Obinutuzumab

    Drug

    Administered intravenously

Treatment groups

80 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Substudy 1 Part 1a: Dose EscalationExperimental treatment 2 interventions
Group B: Substudy 1 Part 1b: Safety ExpansionExperimental treatment 2 interventions
Group C: Substudy 2 Part 1a: Dose EscalationExperimental treatment 2 interventions
Group D: Substudy 2 Part 1b: Safety ExpansionExperimental treatment 2 interventions
Group E: Substudy 3 Part 1a: Dose EscalationExperimental treatment 2 interventions
Group F: Substudy 3 Part 1b: Safety ExpansionExperimental treatment 2 interventions
Group G: Substudy 4 Part 1a: Dose EscalationExperimental treatment 3 interventions
Group H: Substudy 4 Part 1b: Safety ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

Time frame
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
2

Substudy 1 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

Time frame
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
3

Substudy 2 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

Time frame
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
4

Substudy 2 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

Time frame
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years

Secondary outcomes

1

Substudy 1 Parts 1a and 1b: Overall Response Rate (ORR) in participants with B-cell malignancies

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by investigator.

Time frame
Up to approximately 3 years
2

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.

Time frame
Up to approximately 3 years
3

Substudy 1 Parts 1a and 1b: Time to Response (TTR)

TTR is defined as the time from treatment initiation to first documented response.

Time frame
Up to approximately 3 years
4

Substudy 1 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg and sonrotoclax

Time frame
From Week 1 to Week 17

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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