Clinical trial NCT05471843: Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma (MCL)
Relapsed Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma
Lymphoma
MCL
Refractory MCL
Refractory Mantle Cell Lymphoma
Relapsed Mantle Cell Lymphoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. Histologically confirmed diagnosis of MCL
2. 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).
3. Relapsed/refractory disease
4. Presence of measurable disease
5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
7. Adequate organ function

Key Exclusion Criteria:

1. Known central nervous system involvement by lymphoma
2. 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.
3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
4. 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.
5. Clinically significant cardiovascular disease.
6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
7. Active fungal, bacterial or viral infection requiring systemic treatment.

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

Primary outcomes:
measure: Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
timeFrame: Up to 1 Year
measure: Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
timeFrame: Up to 5 Years
measure: Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events
timeFrame: Up to 5 Years
measure: Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
timeFrame: Up to 4 Years
Secondary outcomes:
measure: Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC)
timeFrame: Up to 2 Years
measure: Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 2 Years
measure: Part 1: Single Dose Time to reach Cmax (Tmax)
timeFrame: Up to 2 Years
measure: Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC)
timeFrame: Up to 2 Years
measure: Part 1: Steady State Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 2 Years
measure: Part 1: Steady State Trough Plasma Concentration (CTrough)
timeFrame: Up to 2 Years
measure: Part 1: Steady State Time to reach Cmax (Tmax)
timeFrame: Up to 2 Years
measure: Overall Response Rate (ORR) as assessed by investigator
timeFrame: Up to 4 Years
measure: Duration of Response (DOR) as assessed by investigator and IRC
timeFrame: Up to 4 Years
measure: Progression Free Survival (PFS) as assessed by investigator and IRC
timeFrame: Up to 4 Years
measure: Time to Response (TTR) as assessed by investigator and IRC
timeFrame: Up to 4 Years
measure: Overall Survival (OS)
timeFrame: Up to 4 Years
measure: Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.
timeFrame: Up to 4 Years
measure: Part 2: Number of participants with clinically significant changes from baseline in vital signs
timeFrame: Up to 4 Years
measure: Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values
timeFrame: Up to 4 Years
measure: Part 2: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: Up to 4 Years
measure: Part 2: Participant Reported Outcomes as measured by NFLymSI-18
timeFrame: Up to 4 Years
measure: Part 2: Participant Reported Outcomes as measured by EQ-5D-5L questionnaires
timeFrame: Up to 4 Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham Hospital
state: Alabama
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Des Moines
country: United States
facility: Des Moines Oncology Research Association
state: Iowa
city: New Orleans
country: United States
facility: Tulane Cancer Center
state: Louisiana
city: Annapolis
country: United States
facility: Luminis Health Anne Arundel Medical Center
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology, Pa
state: Maryland
city: Columbia
country: United States
facility: University of Missouri Hospital, Ellis Fischel Cancer Center
state: Missouri
city: Grand Island
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Cancer Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Charlotte
country: United States
facility: Novant Health Hematology Charlotte
state: North Carolina
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Brugge
country: Belgium
facility: Az Sint Jan Brugge
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Roeselare
country: Belgium
facility: AZ DELTA
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro Sa
city: Rio de Janeiro
country: Brazil
facility: Instituto Americas Ensino, Pesquisa E Inovacao
city: Salvador
country: Brazil
facility: Hospital Sao Rafael (Rede Dor)
city: Sao Paulo
country: Brazil
facility: Hospital Beneficencia Portuguesa de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto Dor de Pesquisa E Ensino Sao Paulo
city: Sao Paulo
country: Brazil
facility: Accamargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Halifax
country: Canada
facility: Qeii Health Science Center
state: Nova Scotia
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
state: Anhui
city: Beijing
country: China
facility: China Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University(Tongzhou)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital Huifu Branch
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Nanning
country: China
facility: The Tumor Hospital Affiliated to Guangxi Medical University
state: Guangxi
city: Guiyang
country: China
facility: Cancer Hospital of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Province Cancer Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University Branch West Coast
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology and Hospital of Blood Disease
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Kashgar
country: China
facility: The First Peoples Hospital of Kashgar
state: Xinjiang
city: Urumqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Nantes Cedex
country: France
facility: Centre Hospitalier Universitaire Nantes Hotel Dieu
city: Paris
country: France
facility: Hopital Pitie Salpetriere Service Hematologie
city: Paris
country: France
facility: Necker University Hospital
city: PierreBenite
country: France
facility: Chu Hopital Lyon Sud
city: Tours
country: France
facility: Chu Tours Hopital Bretonneau Service Pneumologie
city: Dusseldorf
country: Germany
facility: Universitatsklinikum Dusseldorf
city: Essen
country: Germany
facility: Universitatsklinikum Essen (Aor)
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein, Campus Kiel
city: Koeln
country: Germany
facility: Universitatsklinikum Koln, Innere Medizin I
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah En Karem Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Tel Aviv Medical Center
city: Bari
country: Italy
facility: Irccs Istituto Tumori Giovanni Paolo Ii
city: Bologna
country: Italy
facility: Policlinico Sorsola Malpighi, Aou Di Bologna
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
city: Novara
country: Italy
facility: Aou Maggiore Della Carita
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Pratia McM Krakow
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr W Lublinie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center
city: Barcelona
country: Spain
facility: Hospital Universitario Vall Dhebron
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
city: Ankara
country: Turkey
facility: Gazi University
city: Atakum Samsun
country: Turkey
facility: Ondokuz Mayis University Medicine Faculty Hospital
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Hospital
city: Istanbul
country: Turkey
facility: Vkv American Hospital
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kayseri
country: Turkey
facility: Erciyes University School of Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Greater Manchester
country: United Kingdom
facility: The Christie Hospital
city: Headington
country: United Kingdom
facility: Churchill Hospital Oxford University Hospital Nhs Trust
city: London
country: United Kingdom
facility: University College Hospital
city: Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre
Study officials:
References: