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

NCT06634589 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: BGB-16673-1042024-516234-35-00CTR20244676
• Study Type: interventional
• Target: 80
• Locations: 8 countries
• Sites: 50

Brief Summary

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.

Conditions

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

Keywords

R/R B-Cell Malignancies; relapsed or refractory B-Cell Malignancies; B-Cell malignancy; BGB-16673; sonrotoclax; zanubrutinib; B-cell lymphoma; Bruton Tyrosine Kinase (BTK); Mosunetuzumab; Glofitamab

Outcome Measures

Primary Outcomes (8)

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

  From 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 events

  From 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 events

  From 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 events

  From 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 events

  From 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 events

  From 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 events

  From 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 events

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

Secondary Outcomes (33)

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

  Up to approximately 3 years

• Substudy 1 Parts 1a and 1b: Duration of Response (DOR)

  Up to approximately 3 years

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

  Up to approximately 3 years

• Substudy 1 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673 and sonrotoclax

  From Week 1 to Week 17

• Substudy 1 Part 1a: Maximum observed concentration (Cmax) of BGB-16673 and sonrotoclax

  From Week 1 to Week 17

Study Arms (8)

Substudy 1 Part 1a: Dose Escalation

EXPERIMENTAL

Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.

Drug: BGB-16673; Drug: Sonrotoclax

Substudy 1 Part 1b: Safety Expansion

EXPERIMENTAL

Cohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.

Drug: BGB-16673; Drug: Sonrotoclax

Substudy 2 Part 1a: Dose Escalation

EXPERIMENTAL

Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.

Drug: BGB-16673; Drug: Zanubrutinib

Substudy 2 Part 1b: Safety Expansion

EXPERIMENTAL

Cohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.

Drug: BGB-16673; Drug: Zanubrutinib

Substudy 3 Part 1a: Dose Escalation

EXPERIMENTAL

Sequential cohorts of increasing dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.

Drug: BGB-16673; Drug: Mosunetuzumab

Substudy 3 Part 1b: Safety Expansion

EXPERIMENTAL

Cohorts of select dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.

Drug: BGB-16673; Drug: Mosunetuzumab

Substudy 4 Part 1a: Dose Escalation

EXPERIMENTAL

Sequential cohorts of increasing dose level combinations of BGB-16673 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: BGB-16673; Drug: Glofitamab; Drug: Obinutuzumab

Substudy 4 Part 1b: Safety Expansion

EXPERIMENTAL

Cohorts of select dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies.

Drug: BGB-16673; Drug: Glofitamab; Drug: Obinutuzumab

Interventions

BGB-16673 DRUG

Administered orally

Substudy 1 Part 1a: Dose Escalation; Substudy 1 Part 1b: Safety Expansion; Substudy 2 Part 1a: Dose Escalation; Substudy 2 Part 1b: Safety Expansion; Substudy 3 Part 1a: Dose Escalation; Substudy 3 Part 1b: Safety Expansion; Substudy 4 Part 1a: Dose Escalation; Substudy 4 Part 1b: Safety Expansion

Sonrotoclax DRUG

Administered orally

Also known as: BGB-11417

Substudy 1 Part 1a: Dose Escalation; Substudy 1 Part 1b: Safety Expansion

Zanubrutinib DRUG

Administered orally

Substudy 2 Part 1a: Dose Escalation; Substudy 2 Part 1b: Safety Expansion

Mosunetuzumab DRUG

Administered subcutaneously

Substudy 3 Part 1a: Dose Escalation; Substudy 3 Part 1b: Safety Expansion

Glofitamab DRUG

Administered intravenously

Substudy 4 Part 1a: Dose Escalation; Substudy 4 Part 1b: Safety Expansion

Obinutuzumab DRUG

Administered intravenously

Substudy 4 Part 1a: Dose Escalation; Substudy 4 Part 1b: Safety Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adequate organ function
• 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 ≥ 7 days after the last dose of sonrotoclax, 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 mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
• 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 ≥ 7 days after the last dose of sonrotoclax, 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 mosunetuzumab
• Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min
• Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression
• Adequate renal function as indicated by eGFR of ≥ 30 mL/min

You may not qualify if:

• 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
• Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
• Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period
• Substudies 1 and 2: 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
• 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
• 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)
• Participants who discontinued prior zanubrutinib treatment due to intolerance
• Prior exposure to a CD20 x CD3 T-cell engager antibody treatment
• All participants with a prior allogeneic stem cell transplant
• Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (50)

Mayo Clinic Phoenix

Phoenix, Arizona, 85054-4502, United States

RECRUITING

University of Southern Californianorris Comprehensive

Los Angeles, California, 90033, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224-1865, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612-9496, United States

RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, 66205-2003, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905-0001, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

RECRUITING

Summit Medical Group

Florham Park, New Jersey, 07932-1049, United States

RECRUITING

Icahn School of Medicine At Mount Sinai

New York, New York, 10029-6504, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Weill Cornell Medical College Newyork Presbyterian Hospital

New York, New York, 10065-4870, United States

RECRUITING

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, 10065-6800, United States

RECRUITING

University of Rochester

Rochester, New York, 14642-0001, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2434, United States

RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

RECRUITING

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53792-0001, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-1222, United States

RECRUITING

St George Hospital

Kogarah, New South Wales, NSW 2217, Australia

RECRUITING

Mater Cancer Care Centre

South Brisbane, Queensland, QLD 4101, Australia

RECRUITING

Monash Health

Clayton, Victoria, VIC 3168, Australia

RECRUITING

Peter Maccallum Cancer Centre

Melbourne, Victoria, VIC 3000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, VIC 3004, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

RECRUITING

Hospital Sirio Libanes Brasilia

Brasília, 70200-730, Brazil

RECRUITING

Ensino E Terapia de Inovacao Clinica Amo Etica

Salvador, 41950-640, Brazil

RECRUITING

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, 15090-000, Brazil

RECRUITING

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900, Brazil

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang, 310002, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

Dresden, 01307, Germany

RECRUITING

Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

Jena, 07747, Germany

RECRUITING

Universitatsklinikum Schleswig Holstein, Campus Kiel

Kiel, 24105, Germany

RECRUITING

Medizinische Universitaetsklinik

Tübingen, 72076, Germany

RECRUITING

Universitaetsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

Bologna, 40138, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

Istituto Nazionale Tumori Fondazione G Pascale

Naples, 80131, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Centroricerche Cliniche Di Verona Srl

Verona, 37134, Italy

RECRUITING

North Shore Hospital

Auckland, 0622, New Zealand

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Lublin, 20-081, Poland

RECRUITING

Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

Olsztyn, 10-228, Poland

RECRUITING

Szpital Wojewodzki W Opolu Sp Z Oo Oddzia Hematologii I Onkologii Hematologicznej

Opole, 45-061, Poland

RECRUITING

Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit

Warsaw, 02-781, Poland

RECRUITING

MeSH Terms

Conditions

Recurrence; Neoplasms; Lymphoma, B-Cell

Interventions

zanubrutinib; glofitamab; obinutuzumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): December 2, 2028
• Study Completion (Estimated): December 2, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

IT (5); BR (4); US (18); PL (5); NZ (2); AU (6); DE (5); CN (5)