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Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader

ConditionsB-cell MalignancyNon-Hodgkin LymphomaMantle Cell LymphomaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaWaldenström MacroglobulinemiaMarginal Zone LymphomaFollicular LymphomaDLBCL UnclassifiableRichter's Transformation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeiGene

About this trial

This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated written informed consent prior to any study

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

Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria

Phase 1: Confirmed diagnosis of R/R Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL/SLL

Disqualifiers

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

Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment

Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.

Current or history of central nervous involvement

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGB-16673

    Drug

    Orally administered

Treatment groups

146 Participants
are divided into 3 treatment groups
Group A: Phase 1a Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b Monotherapy Safety ExpansionExperimental treatment 1 intervention
Group C: Phase 2 Monotherapy Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria.

Time frame
From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)
2

Phase 1: Recommended Phase 2 dose (RP2D) of BGB-16673

As determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, pharmacokinetics, and pharmacodynamics data.

Time frame
From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
3

Phase 1a: Maximum tolerated dose (MTD) of BGB-16673

The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD).

Time frame
From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)
4

Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)

ORR is defined as the percentage of participants with partial response or better according to the Independent Review Committee (IRC) assessment and as determined by Lugano criteria.

Time frame
Up to approximately 3 years

Secondary outcomes

1

Maximum observed plasma concentration (Cmax) After a Single Dose of BGB-16673

Time frame
Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
2

Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of BGB-16673

Time frame
Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
3

Minimum observed plasma concentration (Cmin) After a Single Dose of BGB-16673

Time frame
Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose
4

Apparent terminal elimination half-life (t1/2) After a Single Dose of BGB-16673

Time frame
Phase 1a: Week 1 Day 1 pre-dose up to 72 hours post-dose; Phase 1b: Week 1 Day 1 pre-dose and up to 6 hours post-dose; Phase 2: Week 1 Day 1 pre-dose and up to 8 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeiGene

Lead sponsor

Source ClinicalTrials.gov
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