Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471843
• Other study ID #: BGB-11417-201
• Secondary ID: CTR20221815
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 5, 2022
• Est. completion date: August 2027

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: BeiGene
• Phone: 1.877.828.5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: August 2027
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Relapsed Mantle Cell Lymphoma

Intervention

Drug:
• BGB-11417
Administered orally

Locations

Country	Name	City	State
Argentina	Hospital Aleman	Ciudad Autonoma de Buenos Aires
Belgium	Az Sint Jan Brugge	Brugge
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	University Hospitals Leuven	Leuven
Belgium	AZ DELTA	Roeselare
Brazil	Hospital Erasto Gaertner	Curitiba
Brazil	Hospital Mae de Deus	Porto Alegre
Brazil	Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp	Ribeirao Preto
Brazil	Instituto Americas Ensino, Pesquisa E Inovacao	Rio de Janeiro
Brazil	Oncoclinicas Rio de Janeiro Sa	Rio de Janeiro
Brazil	Hospital Sao Rafael (Rede Dor)	Salvador
Brazil	Accamargo Cancer Center	Sao Paulo
Brazil	Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular	Sao Paulo
Brazil	Hospital Beneficencia Portuguesa de Sao Paulo	Sao Paulo
Brazil	Instituto Dor de Pesquisa E Ensino Sao Paulo	Sao Paulo
Brazil	Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	Sao Paulo
Canada	Qeii Health Science Center	Halifax	Nova Scotia
France	Centre Hospitalier Le Mans	Le Mans
France	Centre Hospitalier Universitaire Nantes Hotel Dieu	Nantes Cedex
France	Hopital Pitie Salpetriere Service Hematologie	Paris
France	Necker University Hospital	Paris
France	Chu Hopital Lyon Sud	PierreBenite
France	Chu Tours Hopital Bretonneau Service Pneumologie	Tours
Germany	Universitatsklinikum Dusseldorf	Dusseldorf
Germany	Universitatsklinikum Essen (Aor)	Essen
Germany	Universitatsklinikum Schleswig Holstein, Campus Kiel	Kiel
Germany	Universitatsklinikum Koln, Innere Medizin I	Koeln
Israel	Assuta Ashdod Medical Center	Ashdod
Israel	Hadassah En Karem Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Petach Tikva
Israel	Sheba Medical Center	Tel Aviv
Israel	Sourasky Tel Aviv Medical Center	Tel Aviv
Italy	Irccs Istituto Tumori Giovanni Paolo Ii	Bari
Italy	Policlinico Sorsola Malpighi, Aou Di Bologna	Bologna
Italy	Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia	Brescia
Italy	Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst	Meldola
Italy	Aou Maggiore Della Carita	Novara
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Pratia McM Krakow	Krakow
Poland	Uniwersytecki Szpital Kliniczny Nr W Lublinie	Lublin
Poland	Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy	Warszawa
Puerto Rico	Auxilio Mutuo Cancer Center	San Juan
Spain	Hospital Universitario Vall Dhebron	Barcelona
Spain	Institut Catala Dandoncologia	Barcelona
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital	Ankara
Turkey	Gazi University	Ankara
Turkey	Ondokuz Mayis University Medicine Faculty Hospital	Atakum Samsun
Turkey	Bagcilar Medipol Mega Hospital	Istanbul
Turkey	Vkv American Hospital	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Erciyes University School of Medicine	Kayseri
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
United Kingdom	The Christie Hospital	Greater Manchester
United Kingdom	Churchill Hospital Oxford University Hospital Nhs Trust	Headington
United Kingdom	University College Hospital	London
United Kingdom	Clatterbridge Cancer Centre	Wirral
United States	Luminis Health Anne Arundel Medical Center	Annapolis	Maryland
United States	University of Alabama At Birmingham Hospital	Birmingham	Alabama
United States	Novant Health Hematology Charlotte	Charlotte	North Carolina
United States	Maryland Oncology Hematology, Pa	Columbia	Maryland
United States	University of Missouri Hospital, Ellis Fischel Cancer Center	Columbia	Missouri
United States	Des Moines Oncology Research Association	Des Moines	Iowa
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Nebraska Cancer Specialists	Grand Island	Nebraska
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The University of Texas Md Anderson Cancer Center	Houston	Texas
United States	Dartmouth Cancer Center	Lebanon	New Hampshire
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Northwest Medical Specialties	Puyallup	Washington
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  France,  Germany,  Israel,  Italy,  Poland,  Puerto Rico,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)		Up to 1 Year
Primary	Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation.		Up to 5 Years
Primary	Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events		Up to 5 Years
Primary	Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)	Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification	Up to 4 Years
Secondary	Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC)		Up to 2 Years
Secondary	Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax)		Up to 2 Years
Secondary	Part 1: Single Dose Time to reach Cmax (Tmax)		Up to 2 Years
Secondary	Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC)		Up to 2 Years
Secondary	Part 1: Steady State Maximum Observed Plasma Concentration (Cmax)		Up to 2 Years
Secondary	Part 1: Steady State Trough Plasma Concentration (CTrough)		Up to 2 Years
Secondary	Part 1: Steady State Time to reach Cmax (Tmax)		Up to 2 Years
Secondary	Overall Response Rate (ORR) as assessed by investigator	Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification	Up to 4 Years
Secondary	Duration of Response (DOR) as assessed by investigator and IRC	DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause; whichever occurs first	Up to 4 Years
Secondary	Progression Free Survival (PFS) as assessed by investigator and IRC	PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.	Up to 4 Years
Secondary	Time to Response (TTR) as assessed by investigator and IRC	TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better	Up to 4 Years
Secondary	Overall Survival (OS)	Defined as time from the start of treatment to the date of death due to any cause	Up to 4 Years
Secondary	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
Secondary	Part 2: Number of participants with clinically significant changes from baseline in vital signs	Vital signs include blood pressure and pulse rate	Up to 4 Years
Secondary	Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values	Laboratory values include hematology, and clinical chemistry	Up to 4 Years
Secondary	Part 2: Number of Participants With Clinically Significant Physical Examination Findings	A Physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems	Up to 4 Years
Secondary	Part 2: Participant Reported Outcomes as measured by NFLymSI-18	The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.	Up to 4 Years
Secondary	Part 2: Participant Reported Outcomes as measured by EQ-5D-5L questionnaires	The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).	Up to 4 Years