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A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02760797
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 14, 2016
First Posted Date  ICMJE May 4, 2016
Last Update Posted Date May 22, 2018
Actual Study Start Date  ICMJE May 9, 2016
Actual Primary Completion Date April 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 6 weeks from Day (D) 1 of Cycle (C) 1 (cycle = 3 weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
Percentage of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: 6 weeks from the first administration of study medication in Cycle 1 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to Emactuzumab [ Time Frame: Predose (PrD) (0 hours [H]) on D1 each cycle (cycle = 3 weeks) until progressive disease (PD) (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall) ]
  • Percentage of Participants with ADAs to RO7009789 [ Time Frame: PrD (0 H) on D1 each cycle (cycle = 3 weeks) until PD (up to 2 years); at 120 days after last dose (up to 2 years overall) ]
  • Serum Maximum Concentration (Cmax) of Emactuzumab [ Time Frame: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details ]
    PrD (0 H), end of infusion (EOI) (infusion = 90 minutes [min]), postdose [5 H] D1 of C1/C4 (cycle = 3 weeks); on D2, 5, 8, 12, 15, 19 of C1/C4; on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)
  • Serum Trough Concentration (Ctrough) of Emactuzumab [ Time Frame: PrD (0 H) on D1 of C2 onwards (cycle = 3 weeks) until PD (up to 2 years) ]
  • Area Under the Concentration-Time Curve (AUC) of Emactuzumab [ Time Frame: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details ]
    PrD (0 H), EOI (infusion = 90 min), postdose [5 H] D1 of C1/C4; on D2, 5, 8, 12, 15, 19 of C1/C4 (cycle = 3 weeks); on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)
  • Total Clearance (CL) of Emactuzumab [ Time Frame: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details ]
    PrD (0 H), EOI (infusion = 90 min), postdose [5 H] D1 of C1/C4; on D2, 5, 8, 12, 15, 19 of C1/C4 (cycle = 3 weeks); on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)
  • Volume of Distribution at Steady State (Vss) of Emactuzumab [ Time Frame: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details ]
    PrD (0 H), EOI (infusion = 90 min), postdose [5 H] D1 of C1/C4; on D2, 5, 8, 12, 15, 19 of C1/C4 (cycle = 3 weeks); on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)
  • Accumulation Ratio of Emactuzumab [ Time Frame: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details ]
    PrD (0 H), EOI (infusion = 90 min), postdose [5 H] D1 of C1/C4; on D2, 5, 8, 12, 15, 19 of C1/C4 (cycle = 3 weeks); on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)
  • Terminal Elimination Half-Life (T1/2) of Emactuzumab [ Time Frame: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details ]
    PrD (0 H), EOI (infusion = 90 min), postdose [5 H] D1 of C1/C4; on D2, 5, 8, 12, 15, 19 of C1/C4 (cycle = 3 weeks); on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)
  • Concentration at Time of Tumor Progression (Cprog) of Emactuzumab According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: At time of PD (up to 2 years) ]
  • Concentration of Emactuzumab at Time of Tumor Response (Complete or Partial Response) According to RECIST v1.1 [ Time Frame: At time of tumor response (up to 2 years) ]
  • Concentration of Emactuzumab at Time of Infusion-Related Reaction (IRR) or Hypersensitivity Reaction [ Time Frame: At time of IRR or hypersensitivity reaction (up to 2 years) ]
  • Cmax of RO7009789 [ Time Frame: PrD (0 H), 15 min during infusion, EOI (infusion = 30 min), postdose (2, 4, 6 H) on D1 of C1 (cycle = 3 weeks); on D2, 3, 8 of C1; PrD (0 H), EOI on D1 of C2 onwards until/at PD (up to 2 years); at 120 days after last dose (up to 2 years overall) ]
  • Ctrough of RO7009789 [ Time Frame: PrD (0 H) on D1 of C2 onwards (cycle = 3 weeks) until PD (up to 2 years) ]
  • AUC of RO7009789 [ Time Frame: PrD (0 H), 15 min during infusion, EOI (infusion = 30 min), postdose (2, 4, 6 H) on D1 of C1 (cycle = 3 weeks); on D2, 3, 8 of C1; PrD (0 H), EOI on D1 of C2 onwards until/at PD (up to 2 years); at 120 days after last dose (up to 2 years overall) ]
  • CL of RO7009789 [ Time Frame: PrD (0 H), 15 min during infusion, EOI (infusion = 30 min), postdose (2, 4, 6 H) on D1 of C1 (cycle = 3 weeks); on D2, 3, 8 of C1; PrD (0 H), EOI on D1 of C2 onwards until/at PD (up to 2 years); at 120 days after last dose (up to 2 years overall) ]
  • Vss of RO7009789 [ Time Frame: PrD (0 H), 15 min during infusion, EOI (infusion = 30 min), postdose (2, 4, 6 H) on D1 of C1 (cycle = 3 weeks); on D2, 3, 8 of C1; PrD (0 H), EOI on D1 of C2 onwards until/at PD (up to 2 years); at 120 days after last dose (up to 2 years overall) ]
  • Accumulation Ratio of RO7009789 [ Time Frame: PrD (0 H), 15 min during infusion, EOI (infusion = 30 min), postdose (2, 4, 6 H) on D1 of C1 (cycle = 3 weeks); on D2, 3, 8 of C1; PrD (0 H), EOI on D1 of C2 onwards until/at PD (up to 2 years); at 120 days after last dose (up to 2 years overall) ]
  • T1/2 of RO7009789 [ Time Frame: PrD (0 H), 15 min during infusion, EOI (infusion = 30 min), postdose (2, 4, 6 H) on D1 of C1 (cycle = 3 weeks); on D2, 3, 8 of C1; PrD (0 H), EOI on D1 of C2 onwards until/at PD (up to 2 years); at 120 days after last dose (up to 2 years overall) ]
  • Total Tumor-Associated Macrophages (TAMs) in Paired-Tumor Biopsies [ Time Frame: Baseline; on D1 of C2 (cycle = 3 weeks); and optionally at time of PD (up to 2 years) ]
  • Total Dermal Macrophages in Paired-Skin Biopsies [ Time Frame: Baseline; on D1 of C2 (cycle = 3 weeks); and optionally at time of PD (up to 2 years) ]
  • Levels of Functional Tumor-Infiltrating Lymphocytes [ Time Frame: Baseline; on D1 of C2 (cycle = 3 weeks); and optionally at time of PD (up to 2 years) ]
  • Circulating Colony-Stimulating Factor (CSF)-1 Serum Levels [ Time Frame: Baseline; on D2, 5, 8, 15 of C1 (cycle = 3 weeks); on D2, 5, 15 of C3; PrD (+/- 1 day) on D1 of each cycle until/at PD (up to 2 years); at 44, 120 days after last dose (up to 2 years overall) ]
  • Total Monocyte Count in Peripheral Blood [ Time Frame: Baseline; on D2, 5, 8, 15 of C1/C3 (cycle = 3 weeks); PrD (+/- 1 day) on D1 of each cycle until/at PD (up to 2 years); at 44, 120 days after last dose (up to 2 years overall) ]
  • Total Dendritic Cell Count in Peripheral Blood [ Time Frame: Baseline; on D2, 5, 8, 15 of C1/C3 (cycle = 3 weeks); PrD (+/- 1 day) on D1 of each cycle until/at PD (up to 2 years); at 44, 120 days after last dose (up to 2 years overall) ]
  • Circulating Cluster of Differentiation (CD) 4 T Cell Count in Peripheral Blood [ Time Frame: Baseline; on D2, 5, 8, 15 of C1/C3 (cycle = 3 weeks); PrD (+/- 1 day) on D1 of each cycle until/at PD (up to 2 years); at 44, 120 days after last dose (up to 2 years overall) ]
  • Circulating CD8 T Cell Count in Peripheral Blood [ Time Frame: Baseline; on D2, 5, 8, 15 of C1/C3 (cycle = 3 weeks); PrD (+/- 1 day) on D1 of each cycle until/at PD (up to 2 years); at 44, 120 days after last dose (up to 2 years overall) ]
  • Circulating B Cell Count in Peripheral Blood [ Time Frame: Baseline; on D2, 5, 8, 15 of C1/C3 (cycle = 3 weeks); PrD (+/- 1 day) on D1 of each cycle until/at PD (up to 2 years); at 44, 120 days after last dose (up to 2 years overall) ]
  • Metabolic Response of Target Lesions Assessed as the Change in Maximum Standardized Uptake Value (SUVmax) on [18F]-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) [ Time Frame: Baseline; on D15 of C1; PrD (+/- 4 days) on D1 of C3 (cycle = 3 weeks) ]
  • Percentage of Participants by Best Overall Response as Assessed by RECIST v1.1 [ Time Frame: Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall) ]
  • Percentage of Participants with Overall Response as Assessed by RECIST v1.1 [ Time Frame: Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall) ]
  • Progressive-Free Survival (PFS) as Assessed by RECIST v1.1 [ Time Frame: From Baseline until death or PD; assessed every 6 weeks (up to 2 years overall) ]
  • Duration of Response (DOR) as Assessed by RECIST v1.1 [ Time Frame: From OR until PD; assessed every 6 weeks (up to 2 years overall) ]
  • Percentage of Participants with Clinical Benefit as Assessed by RECIST v1.1 [ Time Frame: Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall) ]
  • Percentage of Participants by Best Overall Response as Assessed by Modified RECIST [ Time Frame: Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall) ]
  • Percentage of Participants with Overall Response as Assessed by Modified RECIST [ Time Frame: Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall) ]
  • Progressive-Free Survival (PFS) as Assessed by Modified RECIST [ Time Frame: From Baseline until death or PD; assessed every 6 weeks (up to 2 years overall) ]
  • Duration of Response (DOR) as Assessed by Modified RECIST [ Time Frame: From OR until PD; assessed every 6 weeks (up to 2 years overall) ]
  • Percentage of Participants with Clinical Benefit as Assessed by Modified RECIST [ Time Frame: Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Percentage of Participants With Anti-drug Antibodies (ADA) to Emactuzumab [ Time Frame: Predose (Pr-D) on Day 1 (D1) of Cycle 1 (C1, each cycle is 21 days), C2, C3, C4, C6, C7, and every 2 cycles until disease progression (DP) and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Percentage of Participants With ADA to RO7009789 [ Time Frame: Predose on D1 of C1, C2, C3, C4, C6, C7, and every 2 cycles until disease progression and 120 days after last dose (up to 2 years) ]
  • Maximum Serum Concentration (Cmax) of Emactuzumab [ Time Frame: Pr-D, end of infusion (EOI, 90min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Pr-D, EOI(90min) on D1,D2,D5,D8,D15 of C3; Pr-D, EOI(90min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28,44, and 120 days after last dose (up to 2 yrs) ]
  • Serum Concentration of Emactuzumab at the Beginning of Cycle 2 and at the Beginning of Every Subsequent Cycle (Ctrough) [ Time Frame: Predose on D1 of Cycle 2 and D1 of every subsequent cycle until disease progression (up to 2 years) ]
  • Area Under the Concentration-time Curve (AUC) of Emactuzumab [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Total Clearance (CL) of Emactuzumab [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Volume of Distribution at Steady-state (Vss) of Emactuzumab [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Accumulation Ratio of Emactuzumab [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Terminal Elimination Half-life (t1/2) of Emactuzumab [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Concentration of Emactuzumab at the Time of Tumor Progression (Cprog) [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Concentration of Emactuzumab at the time of Tumor Response (Complete Response/Partial Response) [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Concentration of Emactuzumab at the Time of Infusion-related Reaction (IRR) or Hypersensitivity Reaction [ Time Frame: Predose, EOI (90 min), 5 hrs postdose on D1,D2,D5,D8,D12,D15,D19 of C1 and C4; Predose, EOI (90 min) on D1,D2,D5,D8,D15 of C3; Predose, EOI (90 min) on D1 of C2,C6,C7 and every 2 cycles until/at DP and 28, 44, and 120 days after last dose (up to 2 years) ]
  • Cmax of RO7009789 [ Time Frame: Predose, at 15 min during infusion, EOI (30 min), 2, 4, 6, 8, 10 hrs postdose on D1, D2, D3, D8 of C1; predose, EOI (30 min) on D1 of C2, C3, C4, C6, C7 and every 2 cycles until/at disease progression and 120 days after last dose (up to 2 years) ]
  • Ctrough of RO7009789 [ Time Frame: Predose on D1 of Cycle 2 and D1 of every subsequent cycle until disease progression (up to 2 years) ]
  • AUC of RO7009789 [ Time Frame: Predose, at 15 min during infusion, EOI (30 min), 2, 4, 6, 8, 10 hrs postdose on D1, D2, D3, D8 of C1; predose, EOI (30 min) on D1 of C2, C3, C4, C6, C7 and every 2 cycles until/at disease progression and 120 days after last dose (up to 2 years) ]
  • CL of RO7009789 [ Time Frame: Predose, at 15 min during infusion, EOI (30 min), 2, 4, 6, 8, 10 hrs postdose on D1, D2, D3, D8 of C1; predose, EOI (30 min) on D1 of C2, C3, C4, C6, C7 and every 2 cycles until/at disease progression and 120 days after last dose (up to 2 years) ]
  • Vss of RO7009789 [ Time Frame: Predose, at 15 min during infusion, EOI (30 min), 2, 4, 6, 8, 10 hrs postdose on D1, D2, D3, D8 of C1; predose, EOI (30 min) on D1 of C2, C3, C4, C6, C7 and every 2 cycles until/at disease progression and 120 days after last dose (up to 2 years) ]
  • Accumulation Ratio of RO7009789 [ Time Frame: Predose, at 15 min during infusion, EOI (30 min), 2, 4, 6, 8, 10 hrs postdose on D1, D2, D3, D8 of C1; predose, EOI (30 min) on D1 of C2, C3, C4, C6, C7 and every 2 cycles until/at disease progression and 120 days after last dose (up to 2 years) ]
  • t1/2 of RO7009789 [ Time Frame: Predose, at 15 min during infusion, EOI (30 min), 2, 4, 6, 8, 10 hrs postdose on D1, D2, D3, D8 of C1; predose, EOI (30 min) on D1 of C2, C3, C4, C6, C7 and every 2 cycles until/at disease progression and 120 days after last dose (up to 2 years) ]
  • Total Tumor-associated Macrophages (TAMs) in Paired-tumor Biopsies [ Time Frame: Baseline, C2D1, or disease progression whichever occurs first (up to 2 years) ]
  • Total Dermal Macrophages in Paired-skin Biopsies [ Time Frame: Baseline, C2D1, or disease progression whichever occurs first (up to 2 years) ]
  • Levels of Functional Tumor-infiltrating Lymphocytes [ Time Frame: Baseline, D1, D2, D5 of C1, D1, D2, D15 of C3, D1 of C2, C4, C5, C6, C7 and every 2 cycles until/at disease progression and 44 and120 days after last dose (up to 2 years) ]
  • Circulating Colony-stimulating Factor 1 (CSF-1) Serum Levels [ Time Frame: Baseline, D1 of C1, C2, C3, C4, C5, C6, C7 and every 2 cycles until/at disease progression and 44 and120 days after last dose (up to 2 years) ]
  • Total Monocytes Count in Peripheral Blood [ Time Frame: Baseline, D1, D2, D5, D8, D15 of C1, D1, D2, D5, D8, D15 of C3, D1 of C2, C4, C5, C6, C7 and every 2 cycles until/at disease progression and 44 and120 days after last dose (up to 2 years) ]
  • Total Dendritic Cells Count in Peripheral Blood [ Time Frame: Baseline, D1, D2, D5, D8, D15 of C1, D1, D2, D5, D8, D15 of C3, D1 of C2, C4, C5, C6, C7 and every 2 cycles until/at disease progression and 44 and120 days after last dose (up to 2 years) ]
  • Circulating Cluster of Differentiation 4 (CD4) Negative T-Cells Count in Peripheral Blood [ Time Frame: Baseline, D1, D2, D5 of C1, D1, D2, D15 of C3, D1 of C2, C4, C5, C6, C7 and every 2 cycles until/at disease progression and 44 and120 days after last dose (up to 2 years) ]
  • Circulating CD8 Negative T-Cells Count in Peripheral Blood [ Time Frame: Baseline, D1, D2, D5 of C1, D1, D2, D15 of C3, D1 of C2, C4, C5, C6, C7 and every 2 cycles until/at disease progression and 44 and120 days after last dose (up to 2 years) ]
  • Circulating B Cells Count in Peripheral Blood [ Time Frame: Baseline, D1, D2, D5 of C1, D1, D2, D15 of C3, D1 of C2, C4, C5, C6, C7 and every 2 cycles until/at disease progression and 44 and120 days after last dose (up to 2 years) ]
  • Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on [18F]-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) [ Time Frame: Part 2: Baseline,C1D15, C3D1 ]
  • Percentage of Participants With Best Overall Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and Modified RECIST [ Time Frame: Baseline, C3D1, C5D1, C7D1 and every 2 cycles until/at disease progression and 28 days after last dose (up to 2 years) ]
  • Percentage of Participants With Overall Response as Assessed by RECIST v1.1 and Modified RECIST [ Time Frame: Baseline, C3D1, C5D1, C7D1 and every 2 cycles until/at disease progression and 28 days after last dose (up to 2 years) ]
  • Progressive-free Survival (PFS) as Assessed by RECIST v1.1 and Modified RECIST [ Time Frame: Baseline, C3D1, C5D1, C7D1 and every 2 cycles until/at disease progression and 28 days after last dose (up to 2 years) ]
  • Duration of Response (DOR) as Assessed by RECIST v1.1 and Modified RECIST [ Time Frame: Baseline, C3D1, C5D1, C7D1 and every 2 cycles until/at disease progression and 28 days after last dose (up to 2 years) ]
  • Percentage of Participants With Clinical Benefit as Assessed by RECIST v1.1 and Modified RECIST [ Time Frame: Baseline, C3D1, C5D1, C7D1 and every 2 cycles until/at disease progression and 28 days after last dose (up to 2 years) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors
Official Title  ICMJE An Open-Label, Multicenter, Dose-Escalation Phase Ib Study With Expansion Phase to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Emactuzumab and RO7009789 Administered in Combination in Patients With Advanced Solid Tumors
Brief Summary This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in combination in participants with locally advanced or metastatic solid tumors that are not amenable to standard treatment. This study will be conducted in two parts: a dose-finding stage (Part I) and an expansion stage (Part II).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: Emactuzumab
    Emactuzumab will be administered IV every 3 weeks (every cycle) during Part I and every 3 or 6 weeks (every cycle or every other cycle) during Part II.
    Other Name: RO5509554
  • Drug: RO7009789
    RO7009789 will be administered IV every 3 weeks (every cycle).
Study Arms  ICMJE
  • Experimental: Part I (Dose-Finding Stage)
    Emactuzumab and RO7009789 will be administered intravenously (IV) at a starting dose of 500 milligrams (mg) for emactuzumab and 2 mg for RO7009789. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent.
    Interventions:
    • Drug: Emactuzumab
    • Drug: RO7009789
  • Experimental: Part II (Dose Expansion Stage)
    Emactuzumab and RO7009789 will be administered IV at the maximum tolerated dose defined in Part I of the study. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent.
    Interventions:
    • Drug: Emactuzumab
    • Drug: RO7009789
Publications * Machiels JP, Gomez-Roca C, Michot JM, Zamarin D, Mitchell T, Catala G, Eberst L, Jacob W, Jegg AM, Cannarile MA, Watson C, Babitzki G, Korski K, Klaman I, Teixeira P, Hoves S, Ries C, Meneses-Lorente G, Michielin F, Christen R, Rüttinger D, Weisser M, Delord JP, Cassier P. Phase Ib study of anti-CSF-1R antibody emactuzumab in combination with CD40 agonist selicrelumab in advanced solid tumor patients. J Immunother Cancer. 2020 Oct;8(2). pii: e001153. doi: 10.1136/jitc-2020-001153.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
38
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2016)
146
Actual Study Completion Date  ICMJE April 6, 2018
Actual Primary Completion Date April 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Histologically confirmed diagnosis of locally advanced, recurrent, and/or metastatic triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, pancreatic cancer, melanoma, or mesothelioma
  • Radiologically measurable and clinically evaluable disease as per RECIST v1.1
  • Life expectancy of greater than or equal to (>/=) 16 weeks
  • Ability to comply with the collection of tumor biopsies; tumors accessible for biopsy
  • Adequate bone marrow, liver, cardiac, and renal function

Exclusion Criteria:

  • Allergy or hypersensitivity to components of either study drug formulation
  • Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments. Participants with radiographically stable, asymptomatic, previously irradiated lesions are eligible provided participant is >/=4 weeks beyond completion of cranial irradiation and >/=3 weeks off of corticosteroid therapy
  • Participants with leptomeningeal disease; metastases to the brain stem, midbrain, pons, medulla, or within 10 millimeters (mm) of the optic apparatus (optic nerves and chiasm)
  • History of human immunodeficiency virus (HIV)
  • Participants with active hepatitis B, active hepatitis C, or active tuberculosis
  • Pregnant or lactating women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02760797
Other Study ID Numbers  ICMJE BP29427
2015-004348-21 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP