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A Safety and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

NCT02500407

Description:

This is a Phase 1/1b 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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Safety and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
  • Official Title: An Open-Label, Multicenter, Phase I/IB Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: GO29781
  • NCT ID: NCT02500407

Conditions

  • Lymphocytic Leukemia, Chronic
  • Lymphoma, Non Hodgkin

Interventions

DrugSynonymsArms
BTCT4465A (Mosunetuzumab) IVDose Escalation
AtezolizumabTecentriqDose Escalation
BTCT4465A (Mosunetuzumab) SCDose Escalation

Purpose

This is a Phase 1/1b 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.

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalParticipants will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with atezolizumab. Dose escalation will be guided by the observed incidence of DLTs at each dose level.
  • BTCT4465A (Mosunetuzumab) IV
  • Atezolizumab
  • BTCT4465A (Mosunetuzumab) SC
Dose ExpansionExperimentalParticipants will receive BTCT4465A (Mosunetuzumab) at the RP2D as a single-agent or in combination with atezolizumab.
  • BTCT4465A (Mosunetuzumab) IV
  • Atezolizumab
  • BTCT4465A (Mosunetuzumab) SC

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab)
Time Frame: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)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of Response as Assessed Using Standard Criteria for NHL
Time Frame: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)
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) as Assessed Using Standard Criteria for NHL
Time Frame: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)
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:Baseline until death from any cause (up to approximately 4 years)
Safety Issue:
Description:
Measure: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)
Time Frame:Baseline until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 4 years).
Safety Issue:
Description: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
Measure:Objective Response Rate (ORR)
Time Frame: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)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genentech, Inc.

Last Updated

January 6, 2020