BGB-16673 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Linear Clinical Research, Nedlands, Australia
Cancer+8 More
BGB-16673 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies

See full description

Eligible Conditions

  • Cancer
  • Non-hodgkin Lymphoma
  • Waldenström's Macroglobulinemia (WM)
  • Marginal Zone Lymphoma (MZL)
  • B Cell Malignancies
  • Follicular Lymphoma ( FL)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether BGB-16673 will improve 2 primary outcomes and 18 secondary outcomes in patients with Cancer. Measurement will happen over the course of Day 1 pre-dose and 8 hours post-dose (approximately 2 years).

Year 2
Single Dose Area under the plasma concentration-time curve (AUC) of BGB-16673
Single Dose Maximum observed plasma concentration (Cmax) of BGB-16673
Single Dose Minimum observed plasma concentration (Cmin) of BGB-16673
Single Dose Time to reach Cmax (tmax) of BGB-16673
Single Dose Time to reach half of Cmax (T1/2) of BGB-16673
Single Dose accumulation ratios of BGB-16673
Single Dose apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
Single Dose apparent volume of distribution (Vz/F) of BGB-16673
Steady State Area under the plasma concentration-time curve (AUC) of BGB-16673
Steady State Maximum observed plasma concentration (Cmax) of BGB-16673
Steady State Time to reach Cmax (tmax) of BGB-16673
Steady State Time to reach half of Cmax (T1/2) of BGB-16673
Steady State apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
Steady State apparent volume of distribution (Vz/F) of BGB-16673
Steady State minimum observed plasma concentration (Cmin) of BGB-16673
Year 2
BTK protein degradation in peripheral blood upon BGB-16673 monotherapy
approximately 3 years
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE V5.
Number of Participants with overall response rate (ORR)
Number of WM Participants with major response rate (MRR)
Recommended Phase 2 Dose (RP2D) of Orally Administered BGB-16673

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Part 1 Monotherapy Dose Finding
1 of 2
Part 2 Expansion Cohorts
1 of 2
Experimental Treatment

This trial requires 76 total participants across 2 different treatment groups

This trial involves 2 different treatments. BGB-16673 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Part 1 Monotherapy Dose Finding
Drug
BGB-16673
Part 2 Expansion Cohorts
Drug
BGB-11673 for two expansion cohorts

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 3 years for reporting.

Closest Location

The University of Texas, MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
Age ≥ 18 years
Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: MZL, FL, MCL, CLL/SLL, or WM.
Patients who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks.
For dose-finding and dose-expansion, patients who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
Measurable disease by radiographic assessment or serum IgM level (WM only)
ECOG Performance Status of 0 to 2
Patients enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy; patients with CLL/SLL or MCL enrolling in the expansion cohorts must have been treated with a BTKi in a prior line of therapy.

Patient Q&A Section

What are common treatments for follicular lymphoma ( fl)?

"The most common treatments for adult CD30+ B-cell non-Hodgkin's lymphoma include rituximab, cyclophosphamide and doxorubicin. In children, the standard regimen is a combination of rituximab, vincristine, doxorubicin, and prednisone with granulocyte colony-stimulating factor and methotrexate. This is followed by rituximab and CHOP or CHOP-R plus rituximab. These drugs are expensive and often have significant toxicity. Patients have multiple relapses after treatment if they remain in first remission. Many patients will have relapses after that." - Anonymous Online Contributor

Unverified Answer

Can follicular lymphoma ( fl) be cured?

"With a combination of aggressive therapy and bone marrow transplantation, there has been good success in treating fl in certain patients. But relapse is very common, even in patients with high-risk or advanced-stage disease. It is recommended that patients, families, and physicians be familiar with the outcome of fl treatment and consider how to modify treatments to be of more benefit." - Anonymous Online Contributor

Unverified Answer

What are the signs of follicular lymphoma ( fl)?

"Fl presents with nonspecific signs and symptoms including malaise, weight loss, anemia, enlarged lymph nodes, and skin lesions. The signs and symptoms change over time.\n" - Anonymous Online Contributor

Unverified Answer

What causes follicular lymphoma ( fl)?

"biodiversity of the immune system, the endocrine system, external exposure to the sun, a past virus infection, or a defect in B cell proliferation as a result of DNA mutation (mutational signature of fl)\n\na biodiversity of the immune system and the endocrine system; external exposure to the sun, previous infection with Hepatitis C virus; and a mutation in the DNA of some B cell cell lineages\nb." - Anonymous Online Contributor

Unverified Answer

What is follicular lymphoma ( fl)?

"Follicular lymphoma involves a heterogenous group of biologically aggressive diseases. The follicular histology of these neoplasms may be associated with the most favorable outcome. There may be a significant improvement in prognosis over the past 10 years. The use of the "International Prognostic Scoring System" does not seem to be the parameter that leads to the realization of the most appropriate treatment." - Anonymous Online Contributor

Unverified Answer

How many people get follicular lymphoma ( fl) a year in the United States?

"According to reports from the National Cancer Institute, the most common type of non-Hodgkin lymphoma encountered in the United States manifests as follicular lymphoma. It was found that between 1979 and 1984, there were approximately 3,000 new cases of follicular lymphoma registered in the United States each year. In 1986, it was estimated that 5,300 new cases of follicular lymphomas would arise on average each year in the United States alone, with the age of onset between the 4th and 5th decades. It was also noted that these estimates were based on a pooled study, and therefore, the estimates could be more optimistic or pessimistic than the actual incidence over a wider age group." - Anonymous Online Contributor

Unverified Answer

Has bgb-16673 proven to be more effective than a placebo?

"Bgb-16673 has a positive effect on patients with FL. Clinical response was more pronounced (p=0.0037) and disease-free survival time was longer (p=0.0001) in the bgb-16673 group compared to patients who did not receive the drug. Patients with elevated baseline LDH and hemoglobin A(1c) levels had a slightly shorter (1.97, CI: 1.14-3.03) disease-free survival time compared to the control group." - Anonymous Online Contributor

Unverified Answer

How quickly does follicular lymphoma ( fl) spread?

"All patients with fl would benefit from having a systematic assessment of the disease status and the risk factors for spread. In those with fl, the disease status and the risk factors for spread can be calculated. The treatment of patients with fl would be adjusted according to the calculated risk factors; the patients with fl would have early treatment initiated by an appropriate treatment plan." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of bgb-16673?

"The majority of patients suffered from fatigue, nausea, vomiting, constipation, abdominal pain, and fever. None of the patients experienced life-threatening adverse reactions. Data from a recent study show that bgb-16673 is not associated with clinically unacceptable toxicity." - Anonymous Online Contributor

Unverified Answer

What is bgb-16673?

"Bgb-16673 selectively binds human FLs and is also effective in inhibiting FL cell growth. Bgb-16673 and its derivative compounds could serve as potent selective FL therapeutic agents." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for follicular lymphoma ( fl)?

"Currently, most lymphoma patients with a poor prognosis are targeted by clinical trials, as they are younger and healthier. However, when used in this way, clinical trials may result in over-diagnosis and undertreatment for these patients. This situation has to be recognized. Clinical trials should be limited to patients with high-risk features." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating follicular lymphoma ( fl)?

"[At the time of the original paper's publication, a number of treatments had been introduced or are being trialed for the treatment of follicular lymphoma: anti-lymphoma chemotherapy, antibody drugs, autologous stem-cell transplantation, radiation, and a variety of combinations. Many of these treatments have proven to be effective or tolerated, and continue to be developed for future use. In the case of the current clinical trial, no treatments were included, but if a treatment has been successfully demonstrated to be safe and effective, it has the potential to be included in future clinical trial studies. For this reason, and given the high rate of follicular lymphoma, clinicians are encouraged to enroll their patients in clinical trials." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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