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B-cell MalignancyPhase 1/2NCT06634589

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

A Phase 1/2 study testing Tacabrutideg, Sonrotoclax and Zanubrutinib in people with B-cell Malignancy and Relapsed Cancer, run by BeOne Medicines at 49 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tacabrutideg, Sonrotoclax and Zanubrutinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
49 sitesin 8 countries
Study dates
27 Nov 2024to 2 Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 tacabrutideg 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
Show all 12Show fewer
  • 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 tacabrutideg or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab
  • Substudies 1, 3, and 4 Inclusion Criterion:
  • Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min
  • Substudy 2 Inclusion Criteria:
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 tacabrutideg, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab
  • Substudy 1 Exclusion Criterion:
  • 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 2 Exclusion Criterion:
  • Participants who discontinued prior zanubrutinib treatment due to intolerance
  • Substudies 3 and 4 Exclusion Criteria:
  • 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
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

49 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

49 sites in 8 countries

United States17 sites, 17 recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224-1865

    Recruiting

  • University of Southern California Norris Comprehensive

    Los Angeles, California, 90033

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792-0001

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-3522

    Recruiting

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029-6504

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Weill Cornell Medical College Newyork Presbyterian Hospital

    New York, New York, 10065-4870

    Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2434

    Recruiting

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054-4502

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905-0001

    Recruiting

  • University of Rochester

    Rochester, New York, 14642-0001

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9496

    Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205-2003

    Recruiting

Other trials in United States

Australia6 sites, 6 recruiting

  • Monash Health

    Clayton, Victoria, VIC 3168

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, NSW 2217

    Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, VIC 3000

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting

  • Mater Cancer Care Centre

    South Brisbane, Queensland, QLD 4101

    Recruiting

Other trials in Australia

China5 sites, 5 recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang, 310002

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

Other trials in China

Germany5 sites, 5 recruiting

  • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden

    Dresden, 01307

    Recruiting

  • Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

    Jena, 07747

    Recruiting

  • Universitatsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

    Recruiting

  • Medizinische Universitaetsklinik

    Tübingen, 72076

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

Italy5 sites, 5 recruiting

  • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi

    Bologna, 40138

    Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • Istituto Nazionale Tumori Fondazione G Pascale

    Naples, 80131

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • Centroricerche Cliniche Di Verona Srl

    Verona, 37134

    Recruiting

Other trials in Italy

Poland5 sites, 5 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

    Lublin, 20-081

    Recruiting

  • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

    Olsztyn, 10-228

    Recruiting

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

    Opole, 45-061

    Recruiting

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

    Warsaw, 02-781

    Recruiting

Other trials in Poland

Brazil4 sites, 4 recruiting

  • Hospital Sirio Libanes Brasilia

    Brasília, 70200-730

    Recruiting

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    Salvador, 41950-640

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

    Recruiting

Other trials in Brazil

New Zealand2 sites, 2 recruiting

  • North Shore Hospital

    Auckland, 0622

    Recruiting

  • Auckland City Hospital

    Auckland, 1023

    Recruiting

Other trials in New Zealand

About this study

Official title: A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

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.

Read the detailed description

This new study will check how safe and helpful a potential anticancer drug called tacabrutideg 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.

Being tested
Tacabrutideg, Sonrotoclax, Zanubrutinib, Mosunetuzumab, Glofitamab
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, tacabrutideg
Medical subject headings
Recurrence, Neoplasms, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TacabrutidegDrug

    Also called BGB-16673

    Administered orally

  • SonrotoclaxDrug

    Also called BGB-11417

    Administered orally

  • ZanubrutinibDrug

    Administered orally

  • MosunetuzumabDrug

    Administered subcutaneously

  • GlofitamabDrug

    Administered intravenously

  • ObinutuzumabDrug

    Administered intravenously

Study groups in NCT06634589
Study groupRoleWhat they receive
Substudy 1 Part 1a: Dose EscalationExperimentalSequential cohorts of increasing dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Receives: Drug: Tacabrutideg; Drug: Sonrotoclax
Substudy 1 Part 1b: Safety ExpansionExperimentalCohorts of select dose level combinations of tacabrutideg and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Receives: Drug: Tacabrutideg; Drug: Sonrotoclax
Substudy 2 Part 1a: Dose EscalationExperimentalSequential cohorts of increasing dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Receives: Drug: Tacabrutideg; Drug: Zanubrutinib
Substudy 2 Part 1b: Safety ExpansionExperimentalCohorts of select dose level combinations of tacabrutideg and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Receives: Drug: Tacabrutideg; Drug: Zanubrutinib
Substudy 3 Part 1a: Dose EscalationExperimentalSequential cohorts of increasing dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Receives: Drug: Tacabrutideg; Drug: Mosunetuzumab
Substudy 3 Part 1b: Safety ExpansionExperimentalCohorts of select dose level combinations of tacabrutideg and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Receives: Drug: Tacabrutideg; Drug: Mosunetuzumab
Substudy 4 Part 1a: Dose EscalationExperimentalSequential 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.
Receives: Drug: Tacabrutideg; Drug: Glofitamab; Drug: Obinutuzumab
Substudy 4 Part 1b: Safety ExpansionExperimentalCohorts of select dose level combinations of tacabrutideg and glofitamab will be evaluated in participants with selected B-cell malignancies.
Receives: Drug: Tacabrutideg; Drug: Glofitamab; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 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

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

  5. Substudy 3 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

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

  6. Substudy 3 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

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

  7. Substudy 4 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

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

  8. Substudy 4 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events

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

Secondary outcomes (33)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Up to approximately 3 years

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

    Measured: From Week 1 to Week 17

  5. Substudy 1 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg and sonrotoclax

    Measured: From Week 1 to Week 17

  6. Substudy 1 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg and sonrotoclax

    Measured: From Week 1 to Week 17

  7. Substudy 1 Part 1a: Terminal half-life (t1/2) of tacabrutideg and sonrotoclax

    Measured: From Week 1 to Week 17

  8. Substudy 1 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg and sonrotoclax

    Measured: From Week 1 to Week 17

  9. 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)

    Measured: Up to approximately 3 years

  10. Substudy 2 Parts 1a and 1b: 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 the investigator.

    Measured: Up to approximately 3 years

  11. Substudy 2 Parts 1a and 1b: DOR

    DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  12. Substudy 2 Parts 1a and 1b: TTR

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

    Measured: Up to approximately 3 years

  13. Substudy 2 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg and zanubrutinib

    Measured: From Week 1 to Week 17

  14. Substudy 2 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg and zanubrutinib

    Measured: From Week 1 to Week 17

  15. Substudy 2 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg and zanubrutinib

    Measured: From Week 1 to Week 17

  16. Substudy 2 Part 1a: Terminal half-life (t1/2) of tacabrutideg and zanubrutinib

    Measured: From Week 1 to Week 17

  17. Substudy 2 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg and zanubrutinib

    Measured: From Week 1 to Week 17 for Part 1a; From Week 1 to Week 5 for Part 1b

  18. Substudy 3 Parts 1a and 1b: 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 the investigator.

    Measured: Up to approximately 3 years

  19. Substudy 3 Parts 1a and 1b: DOR

    DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  20. Substudy 3 Parts 1a and 1b: TTR

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

    Measured: Up to approximately 3 years

  21. Substudy 3 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg and mosunetuzumab

    Measured: From Week 1 to Week 12

  22. Substudy 3 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg and mosunetuzumab

    Measured: From Week 1 to Week 12

  23. Substudy 3 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg and mosunetuzumab

    Measured: From Week 1 to Week 12

  24. Substudy 3 Part 1a: Terminal half-life (t1/2) of tacabrutideg and mosunetuzumab

    Measured: From Week 1 to Week 12

  25. Substudy 3 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg and mosunetuzumab

    Measured: From Week 1 to Week 36

  26. Substudy 4 Parts 1a and 1b: ORR in participants with B-cell malignancies

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

    Measured: Up to approximately 3 years

  27. Substudy 4 Parts 1a and 1b: DOR

    DOR is defined as the time from the first documented response to documented disease progression or death, whichever occurs first.

    Measured: Up to approximately 3 years

  28. Substudy 4 Parts 1a and 1b: TTR

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

    Measured: Up to approximately 3 years

  29. Substudy 4 Part 1a: Area under the plasma concentration-time curve (AUC) of tacabrutideg

    Measured: From Week 1 to Week 10

  30. Substudy 4 Part 1a: Maximum observed concentration (Cmax) of tacabrutideg

    Measured: From Week 1 to Week 10

  31. Substudy 4 Part 1a: Time to maximum concentration (Tmax) of tacabrutideg

    Measured: From Week 1 to Week 10

  32. Substudy 4 Part 1a: Terminal half-life (t1/2) of tacabrutideg

    Measured: From Week 1 to Week 10

  33. Substudy 4 Parts 1a and 1b: Trough concentration (Ctrough) of tacabrutideg

    Measured: From Week 1 to Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start27 Nov 2024
  3. Primary completion2 Dec 2028 (estimated)
  4. Study completion2 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06634589
Sponsor's protocol ID
BGB-16673-104
Other IDs
2024-516234-35-00, CTR20244676
Status last verified
Sep 2026
First submitted
8 Oct 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tacabrutideg, Sonrotoclax and Zanubrutinib in people with B-cell Malignancy and Relapsed Cancer, run by BeOne Medicines at 49 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Australia, China, Germany, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06634589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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