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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tacabrutideg — DRUG
  Administered orally
• Sonrotoclax — DRUG
  Administered orally
• Zanubrutinib — DRUG
  Administered orally
• Mosunetuzumab — DRUG
  Administered subcutaneously
• Glofitamab — DRUG
  Administered intravenously
• Obinutuzumab — DRUG
  Administered intravenously

Study Details

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.

Key Dates

First listed

Oct 10, 2024

Start date

Nov 27, 2024

Status verified

Aug 2026

Primary completion

Dec 2, 2028

Completion

Dec 2, 2029

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Primary Outcome Measure

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 ]

Central Contacts

• Study Director
  1.877.828.5568
  [email protected]

Locations (18)

Find similar trials in Phoenix, AZ

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