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

Overview

About this study

This study consists of two parts to explore BGB-16673 recommended dosing:  a part 1 monotherapy dose finding and a part 2 (cohort expansion in two cohorts).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Provision of signed and dated written informed consent prior to any study-specific
procedures, sampling, or data collection

2. Age ≥ 18 years

3. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise
noted) of one of the following: MZL, FL, MCL, CLL/SLL, or WM.

4. 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.

5. 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.

6. Measurable disease by radiographic assessment or serum IgM level (WM only)

7. ECOG Performance Status of 0 to 2

8. 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.

Exclusion Criteria:

1. Prior malignancy (other than the disease under study) within the past 2 years, except
for curatively treated basal or squamous skin cancer, superficial bladder cancer,
carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate
cancer

2. Requires ongoing systemic treatment for any other malignancy

3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent)
corticosteroid treatment.

4. Current or history of central nervous system involvement including the brain, spinal
cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or
biopsy) by B-cell malignancy, regardless of whether patient had received treatment for
central nervous system disease

5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt
lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman
disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, or
history of or currently suspected Richter's transformation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/21/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wei Ding, M.B.B.S., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jose Leis, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Ricardo Parrondo, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions