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Tests treatment safety and results for B-cell Malignancy
Official title A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
ClinicalTrials.gov ID: NCT06634589
What this study is testing
What is BGB-16673?
BGB-16673 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for b-cell malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and...
- 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
You likely can't join 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- Substudies 1, 3, and 4 Inclusion Criterion:
- Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min
- Substudy 2
- 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 Key
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Westwood, Kansas, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Florham Park, New Jersey, United States
- New York, New York, United States
- Rochester, New York, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Madison, Wisconsin, United States
- Milwaukee, Wisconsin, United States
- Kogarah, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Clayton, Victoria, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Westwood, Kansas, United States; Rochester, Minnesota, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.