NCT05471843
Active, not recruiting
Phase 1
A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BCL2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- BeiGene
- Enrollment
- 125
- Locations
- 104
- Primary Endpoint
- Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Overview
Brief Summary
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed diagnosis of MCL
- •Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).
- •Relapsed/refractory disease
- •Presence of measurable disease
- •Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or
- •Adequate organ function
Exclusion Criteria
- •Known central nervous system involvement by lymphoma
- •Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
- •Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
- •Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
- •Clinically significant cardiovascular disease.
- •Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
- •Active fungal, bacterial or viral infection requiring systemic treatment.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Single Arm
Experimental
Participants will receive sonrotoclax
Intervention: BGB-11417 (Drug)
Outcomes
Primary Outcomes
Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time Frame: Up to 1 Year
Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
Time Frame: Up to 5 Years
Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events
Time Frame: Up to 5 Years
Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Time Frame: Up to 4 Years
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification
Secondary Outcomes
- Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC)(Up to 2 Years)
- Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax)(Up to 2 Years)
- Part 1: Single Dose Time to reach Cmax (Tmax)(Up to 2 Years)
- Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC)(Up to 2 Years)
- Part 1: Steady State Maximum Observed Plasma Concentration (Cmax)(Up to 2 Years)
- Part 1: Steady State Trough Plasma Concentration (CTrough)(Up to 2 Years)
- Part 1: Steady State Time to reach Cmax (Tmax)(Up to 2 Years)
- Overall Response Rate (ORR) as assessed by investigator(Up to 4 Years)
- Duration of Response (DOR) as assessed by investigator and IRC(Up to 4 Years)
- Progression Free Survival (PFS) as assessed by investigator and IRC(Up to 4 Years)
- Time to Response (TTR) as assessed by investigator and IRC(Up to 4 Years)
- Overall Survival (OS)(Up to 4 Years)
- Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.(Up to 4 Years)
- Part 2: Number of participants with clinically significant changes from baseline in vital signs(Up to 4 Years)
- Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values(Up to 4 Years)
- Part 2: Number of Participants With Clinically Significant Physical Examination Findings(Up to 4 Years)
- Part 2: Participant Reported Outcomes as measured by NFLymSI-18(Up to 4 Years)
- Part 2: Participant Reported Outcomes as measured by EQ-5D-5L questionnaires(Up to 4 Years)
Investigators
Study Sites (104)
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