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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02500407
Other study ID # GO29781
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 15, 2015
Est. completion date November 15, 2025

Study information

Verified date May 2024
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 836
Est. completion date November 15, 2025
Est. primary completion date November 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival - Adequate hepatic, hematologic, and renal function Key Exclusion Criteria: - Pregnant or lactating women - Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug - Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration - Systemic immunosuppressive medication within 2 weeks prior to study drug - Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation - Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia - History of central nervous system (CNS) lymphoma or other CNS disease - Significant cardiovascular or pulmonary disease - Hepatitis B or C or human immunodeficiency virus (HIV) - Receipt of a live attenuated vaccine within 4 weeks prior to study drug - Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BTCT4465A (Mosunetuzumab) IV
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
Atezolizumab
Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
BTCT4465A (Mosunetuzumab) SC
Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.

Locations

Country Name City State
Australia Royal Adelaide Hospital; Haematology Clinical Trials Adelaide South Australia
Australia Monash Health Clinical Trial Pharmacy department Clayton Victoria
Australia St Vincent's Hospital Sydney Darlinghurst New South Wales
Australia St. Vincent's Hospital Melbourne Fitzroy South Australia
Australia Royal Hobart Hospital Hobart Tasmania
Australia The Alfred Melbourne Victoria
Australia Linear Clinical Research Limited Nedlands Western Australia
Australia The Perth Blood Institute Nedlands Western Australia
Australia Icon Cancer Care South Brisbane South Brisbane Queensland
Australia Wollongong Hospital; Cancer Care Centre Wollongong New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland
Canada Jewish General Hospital; Research Unit Montréal Quebec
Canada Princess Margaret Hospital; Department of Med Oncology Toronto Ontario
Canada BC Cancer Agency Vancouver Centre - PARENT Vancouver British Columbia
Germany DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie Bremen
Germany St. Johannes Hospital; Abt. für Hämatologie und Onkologie Dortmund
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Universitatsklinikum Koln; Apotheke Uniklinik Koln Koln
Germany Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz
Germany Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III München
Germany Universitatsklinikum Munster Münster
Germany Universitätsklinikum Würzburg Würzburg
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Spain Hospital Universitario Vall d Hebron Barcelona
Spain Hospital Universitario La Paz Madrid
Spain Clínica Universidad de Navarra Pamplona Navarra
Spain Complejo Asistencial Universitario de Salamanca Salamanca
United Kingdom Barts Cancer Institute London
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Royal Marsden Hospital; Institute of Cancer Research; Pharmacy Stores Sutton
United States Memorial Sloan Kettering Cancer Center - Commack Commack New York
United States Memorial Sloan-Kettering Cancer Center Commack New York
United States Rocky Mountain Cancer Center Denver Colorado
United States City of Hope National Medical Center Duarte California
United States Hackensack University Medical Center Hackensack New Jersey
United States Memorial Sloan Kettering Cancer Center at Westchester Harrison New York
United States MD Anderson Cancer Center Houston Texas
United States University of California San Diego Moores Cancer Center La Jolla California
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Tennessee Oncology - Nashville Nashville Tennessee
United States Yale University School Of Medicine New Haven Connecticut
United States New York Uni Medical Center New York New York
United States University of Pennsylvania; School of Medicine Philadelphia Pennsylvania
United States Washington University; Wash Uni. Sch. Of Med Saint Louis Missouri
United States Sansum Medical Clinic, Inc. Santa Barbara California
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Willamette Valley Cancer Insitute and Research Center Springfield Oregon

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab) BTCT4465A (Mosunetuzumab) single agent: Cycle 1; BTCT4465A (Mosunetuzumab) in combination with atezolizumab: during the first cycle that BTCT4465A (Mosunetuzumab) and atezolizumab are administered concurrently (cycle length = 21 days)
Primary Percentage of Participants With Adverse Events Cycle 1 Day 1 until 90 days after the last infusion (cycle length = 21 days; up to approximately 14 months)
Primary BTCT4465A (Mosunetuzumab) Serum Concentration Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Primary Atezolizumab Serum Concentration Baseline up to 30 days after the last infusion of BTCT4465A (Mosunetuzumab) (up to approximately 12 months)
Primary Percentage of Participants with Complete Response as Assessed Using Standard Criteria for NHL Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Secondary Duration of Response as Assessed Using Standard Criteria for NHL Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
Secondary Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, withdrawal, or death from any cause)
Secondary Overall Survival Baseline until death from any cause (up to approximately 4 years)
Secondary European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Scores to Assess Health-Related Quality of Life (HRQoL) The Functional Assessment of Cancer Therapy-Lymphoma (FACT-lym) Subscale, and the EuroQol 5 Dimension-5 Level (EQ-5D-5L) Questionnaire scores will also be used to assess HRQoL Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).
Secondary Objective Response Rate (ORR) Baseline up to approximately 4 years (assessed at screening and then every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal)
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