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

• Status: Recruiting
• Trial end date: 2024-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

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 BTK inhibitor in any line of therapy must have received only 1 BTK inhibitor-containing regimen and must have received treatment with the BTK inhibitor for ≥ 8 weeks. Patients may have received treatment with 2 different BTKi if the initial BTKi was discontinued secondary to treatment-emergent toxicity.

5. For dose-finding and dose-expansion, patients who had previously received a 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, blastoid-variant MCL, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, or

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