What side effects are associated with this type of intervention?

Common treatments for B-Cell cancers, such as chemotherapy, targeted therapies (e.g., ibrutinib), and immunotherapies, often have a range of side effects. Chemotherapy can cause myelosuppression, leading to neutropenia, anemia, and thrombocytopenia, as well as gastrointestinal issues like nausea and vomiting. Targeted therapies, such as ibrutinib, may result in hematologic adverse effects, including bleeding and infections, as well as non-hematologic effects like hypertension and atrial fibrillation. Immunotherapies can lead to immune-related adverse events, including colitis, dermatitis, and endocrinopathies. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of B-Cell cancers, including ibrutinib, acalabrutinib, and venetoclax. Ibrutinib and acalabrutinib are Bruton tyrosine kinase (BTK) inhibitors, which block a key enzyme in the B-Cell receptor signaling pathway, thereby inhibiting cancer cell growth. Venetoclax is a BCL-2 inhibitor that promotes cancer cell death by targeting the BCL-2 protein, which helps cancer cells survive. These drugs are used to treat various B-Cell malignancies such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), and they represent significant advancements in targeted cancer therapy.

What other types of research exist?

Promising novel alternatives for B-Cell cancers include: 1) Ibrutinib, a BTK inhibitor, which has shown high overall response rates and improved progression-free survival in CLL. 2) Acalabrutinib, another BTK inhibitor, which has demonstrated efficacy in relapsed/refractory mantle cell lymphoma. 3) Venetoclax, a Bcl-2 inhibitor, which is effective in combination with other anti-tumor drugs. 4) Lenalidomide, an immunomodulatory drug, which has shown high response rates in relapsed/refractory mantle cell lymphoma. These therapies have been evaluated in clinical trials and have shown promising results for B-Cell malignancies.

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Small Molecule Inhibitor

BGB-16673 for B-Cell Cancers

Phase 1 & 2

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Requires ongoing systemic corticosteroid treatment

Current or history of central nervous system involvement by B-cell malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called BGB-16673 to find the best dose for patients. It aims to determine how well the drug works and its safety. The study involves finding the right dose and expanding testing to more patients.

Who is the study for?

This trial is for people with certain B-cell malignancies, including various types of lymphoma and leukemia. Participants must have measurable disease, may have had previous treatments (specific conditions apply), and should be in a relatively stable condition as indicated by an ECOG score of 0 to 2. Those who've had other cancers within the last two years or require ongoing treatment for another cancer are not eligible.

What is being tested?

The study tests BGB-16673's optimal dosing levels in two parts: first, finding the right dose through monotherapy escalation; second, expanding safety studies at selected doses. It aims to determine how well this drug can treat different B-cell malignancies when given alone.

What are the potential side effects?

While specific side effects for BGB-16673 aren't listed here, similar drugs often cause fatigue, digestive issues like nausea or diarrhea, blood disorders such as low platelet counts or anemia, infections due to weakened immune systems, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on long-term steroid medication.

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My B-cell cancer has affected or previously affected my brain or spinal cord.

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I have a specific type of blood cancer or lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-16673

Phase 1: Number of Participants with Adverse Events (AEs)

Phase 1: Recommended dose(s) for Expansion (RDFE) of BGB-16673

+1 more

Secondary study objectives

Phase 1: Number of Participants with AEs in part 1e (Japan-only cohort )

Phase 1: Number of R/R WM Participants with major response rate (MRR)

Phase 1: Overall response rate (ORR)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Phase 2 (Monotherapy Expansion)Experimental Treatment1 Intervention

Cohorts of participants with R/R CLL/SLL, R/R MCL, R/R WM, R/R MZL, R/R FL, R/R RT, and R/R DLBCL will be enrolled to recieve the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of BGB-16673.

Group II: Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies)Experimental Treatment1 Intervention

Participants with CLL/SLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels.

Group III: Part 1e (Japan-only Cohort)Experimental Treatment1 Intervention

Japanese participants with R/R MZL, FL, MCL, CLL/SLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of BGB-16673.

Group IV: Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL)Experimental Treatment1 Intervention

Participants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for BGB-16673.

Group V: Part 1c (Additional Monotherapy Safety Expansion)Experimental Treatment1 Intervention

Additional safety data will be collected from participants with R/R MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of BGB-16673 for those with non-CLL/SLL/MCL histologies.

Group VI: Part 1b (Monotherapy Safety Expansion)Experimental Treatment1 Intervention

Participants with R/R MZL, MCL, CLL/SLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for BGB-16673.

Group VII: Part 1a (Monotherapy Dose Escalation)Experimental Treatment1 Intervention

Dose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R/R) marginal zone lymphoma (MZL), relapsed or refractory (R/R) follicular lymphoma (FL) Grades 1, 2, and 3a, relapsed or refractory (R/R) mantle cell lymphoma (MCL), relapsed or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), relapsed or refractory (R/R) Richter's transformation (RT), and relapsed or refractory (R/R) Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of BGB-16673.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bruton tyrosine kinase (BTK) inhibitors, such as ibrutinib, are a common treatment for B-Cell Cancers. BTK is a crucial enzyme in the B-cell receptor (BCR) signaling pathway, which is essential for the growth and survival of B-cell malignancies. By inhibiting BTK, these drugs disrupt the BCR signaling, leading to reduced proliferation and increased apoptosis of malignant B-cells. This mechanism is particularly effective in tumors with certain genetic mutations, such as MYD88 mutations, which are common in B-Cell Cancers. The effectiveness of BTK inhibitors in targeting these pathways makes them a vital option for patients, offering improved response rates and progression-free survival.

Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.Pharmacogenetic considerations for non-Hodgkin's lymphoma therapy.New drugs for the treatment of advanced-stage diffuse large cell lymphomas.