A Phase 1 Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand... | Not Recruiting
A Phase 1 Study of Atezolizumab (an... | Not Recruiting
A Phase 1 Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

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Medical Conditions
  • Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01375842

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent by intravenous (IV) infusion every three weeks (q3w) to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
Research Details
    Sorry, this information is not available
Phase
Phase 1
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Atezolizumab

Study Arm Groups : Dose Escalation Cohort (Atezolizumab 0.01 mg/kg), Dose Escalation Cohort (Atezolizumab 0.03 mg/kg), Dose Escalation Cohort (Atezolizumab 0.1 mg/kg), Dose Escalation Cohort (Atezolizumab 0.3 mg/kg), Dose Escalation Cohort (Atezolizumab 1 mg/kg), Dose Escalation Cohort (Atezolizumab 3 mg/kg), Dose Escalation Cohort (Atezolizumab 10 mg/kg), Dose Escalation Cohort (Atezolizumab 20 mg/kg), Expansion Cohort (Atezolizumab)

Intervention Type
See Interventions above
Primary Outcome Measures
    Number of Participants With Dose Limiting Toxicities (DLTs); Day (D) 1 up to D21; Maximum Tolerated Dose (MTD) of Atezolizumab; D1 up to D21; Recommended Phase 2 Dose (RP2D) of Atezolizumab; Baseline up to time of determination of MTD (up to D21); Percentage of Participants With Adverse Events; Baseline up to 90 days after the last dose of study treatment (ST) or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately [app] 5 years [yrs])
Secondary Outcome Measures
    Percentage of Participants With Anti-Therapeutic Antibodies (ATAs); Predose (prd;0hour[h]) on D1 of Cycle (Cy) 1,2,4,8,16,17,20 (1 Cy=21 days), every 8 cycles thereafter at treatment discontinuation (TD) & then every 30 days (up to 120 days) after last dose of ST/TD, death/closing of study (up to app 5 yrs); Area Under the Concentration-Time Curve (AUC) of Atezolizumab; Prd (0h),0.5h post dose on D1 of Cy 1-5,7 (1Cy=21 days);D2,4,8,15 of Cy1;prd(0h) on D1 of Cy 8,10,12,14,16,17,20, every 8 cycles thereafter & then up to every 30 days (up to 120 days) after last dose of ST/TD, death or closing of study (up to app 5 yrs); Maximum Serum Concentration (Cmax) of Atezolizumab; Prd (0h),0.5h post dose on D1 of Cy 1-5,7 (1Cy=21 days);D2,4,8,15 of Cy1;prd(0h) on D1 of Cy 8,10,12,14,16,17,20, every 8 cycles thereafter & then up to every 30 days (up to 120 days) after last dose of ST/TD, death or closing of study (up to app 5 yrs); Minimum Serum Concentration (Cmin) of Atezolizumab; Prd (0h) on D1 of Cy1,2,3,4,5,7,8,10,12,14,16,17,20 (1Cy=21 days), every 8 cycles upto every 30 days (up to 120 days) after last dose of ST or TD, death or closing of study (up to approximately 5 yrs); Clearance (CL) of Atezolizumab; Prd (0h),0.5h post dose on D1 of Cy 1-5,7 (1Cy=21 days);D2,4,8,15 of Cy1;prd(0h) on D1 of Cy 8,10,12,14,16,17,20, every 8 cycles thereafter & then up to every 30 days (up to 120 days) after last dose of ST/TD, death or closing of study (up to app 5 yrs); Volume at Steady State (Vss) of Atezolizumab; Prd (0h),0.5h post dose on D1 of Cy 1-5,7 (1Cy=21 days);D2,4,8,15 of Cy1;prd(0h) on D1 of Cy 8,10,12,14,16,17,20, every 8 cycles thereafter & then up to every 30 days (up to 120 days) after last dose of ST/TD, death or closing of study (up to app 5 yrs); Percentage of Participants With Best Overall Response, Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and Immune-Related Response Criteria (irRC); Baseline up to approximately 5 years (assessed every 6 weeks for 24 weeks therafter every 12 weeks until disease progression or death or initiation of further systemic cancer therapy up to app 5 years); Percentage of Participants With Objective Response, Assessed by RECIST v1.1 and irRC; Baseline, every 6 weeks for 24 weeks and every 12 weeks thereafter until disease progression, death or initiation of further systemic cancer therapy (up to approximately 5 years); Duration of Objective Response, Assessed by RECIST v1.1 and irRC; Baseline, every 6 weeks for 24 weeks and every 12 weeks thereafter until disease progression, death or initiation of further systemic cancer therapy (up to approximately 5 years); Progression-Free Survival (PFS), Assessed by RECIST v1.1 and irRC; Baseline, every 6 weeks for 24 weeks and every 12 weeks thereafter until disease progression, death or initiation of further systemic cancer therapy (up to approximately 5 years)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Age greater than equal to [>/=] 18 years, participants who are 16 to 17 years old would be enrolled after consultation with the Medical Monitor

    - Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists

    - Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report

    - Adequate hematologic and end organ function

    - Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma

    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    - For participants who will undergo serial biopsy dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (>/=5 millimeter [mm] in diameter amenable to serial biopsy)

    Exclusion Criteria:

    - Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases

    - Known hypersensitivity to pharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

    - History or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis)

    - History of human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection

    - Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1

    - Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1

    - Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
EC1A 7BE
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
France, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase I, Open Label, Dose Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously As a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
PCD4989g
Sponsor(s)
Genentech, Inc.
Key Dates

Recruitment Start Date

Jun 2011

Recruitment End Date

Sep 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

16 Jun 2011

Date updated in source

05 May 2017