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History of Changes for Study: NCT02760797
A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors
Latest version (submitted May 21, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 2, 2016 None (earliest Version on record)
2 June 20, 2016 Study Status and Contacts/Locations
3 August 9, 2016 Study Status, Contacts/Locations, Study Design and Study Identification
4 September 1, 2016 Study Status
5 October 3, 2016 Study Status and Contacts/Locations
6 November 1, 2016 Study Status and Contacts/Locations
7 August 29, 2017 Study Status, Outcome Measures, Contacts/Locations, Arms and Interventions, Study Identification, Eligibility, Study Design, Conditions and Study Description
8 October 10, 2017 Study Status and Contacts/Locations
9 November 8, 2017 Study Status and Contacts/Locations
10 December 7, 2017 Study Status
11 January 4, 2018 Study Status
12 February 28, 2018 Study Status and Contacts/Locations
13 March 26, 2018 Study Status and Contacts/Locations
14 April 23, 2018 Recruitment Status, Study Status and Contacts/Locations
15 May 1, 2018 Recruitment Status, Study Status and Study Design
16 May 21, 2018 Study Status
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Study NCT02760797
Submitted Date:  May 2, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: BP29427
Brief Title: A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors
Official Title: 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
Secondary IDs: 2015-004348-21 [EudraCT Number]
Open or close this module Study Status
Record Verification: May 2016
Overall Status: Recruiting
Study Start: April 2016
Primary Completion: July 2018 [Anticipated]
Study Completion: July 2018 [Anticipated]
First Submitted: April 14, 2016
First Submitted that
Met QC Criteria:
May 2, 2016
First Posted: May 4, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 2, 2016
Last Update Posted: May 4, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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 advanced solid tumors. This study will be conducted in two parts: dose escalation stage (Part 1) and an expansion stage (Part 2).
Detailed Description:
Open or close this module Conditions
Conditions: Solid Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 146 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part 1 (Dose Escalation): Emactuzumab + RO7009789
Emactuzumab and RO7009789 will be administered intravenously (IV) at a starting dose of 500 milligrams (mg) for emactuzumab and 2 mg for RO7009789. Treatments will continue maximum up to 2 years.
Drug: Emactuzumab
Emactuzumab will be administered IV maximum up to 2 years.
Other Names:
  • RO5509554
Drug: RO7009789
RO7009789 will be administered IV maximum up to 2 years.
Experimental: Part 2 (Dose Expansion): Emactuzumab + RO7009789
Emactuzumab and RO7009789 will be administered IV at the maximum tolerated dose defined in Part 1 of the study. Treatments will continue maximum up to 2 years.
Drug: Emactuzumab
Emactuzumab will be administered IV maximum up to 2 years.
Other Names:
  • RO5509554
Drug: RO7009789
RO7009789 will be administered IV maximum up to 2 years.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants With Dose-limiting Toxicities (DLTs)
[ Time Frame: 6 weeks from the first administration of study medication in Cycle 1 ]

Secondary Outcome Measures:
1. 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) ]

2. 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) ]

3. 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) ]

4. 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) ]

5. 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) ]

6. 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) ]

7. 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) ]

8. 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) ]

9. 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) ]

10. 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) ]

11. 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) ]

12. 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) ]

13. 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) ]

14. Ctrough of RO7009789
[ Time Frame: Predose on D1 of Cycle 2 and D1 of every subsequent cycle until disease progression (up to 2 years) ]

15. 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) ]

16. 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) ]

17. 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) ]

18. 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) ]

19. 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) ]

20. Total Tumor-associated Macrophages (TAMs) in Paired-tumor Biopsies
[ Time Frame: Baseline, C2D1, or disease progression whichever occurs first (up to 2 years) ]

21. Total Dermal Macrophages in Paired-skin Biopsies
[ Time Frame: Baseline, C2D1, or disease progression whichever occurs first (up to 2 years) ]

22. 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) ]

23. 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) ]

24. 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) ]

25. 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) ]

26. 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) ]

27. 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) ]

28. 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) ]

29. 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 ]

30. 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) ]

31. 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) ]

32. 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) ]

33. 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) ]

34. 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) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Participants must have histologically confirmed diagnosis of locally advanced 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 version 1.1
  • Life expectancy of greater than or equal to (>=) 16 weeks
  • Ability to comply with the collection of tumor biopsies; tumors must be 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 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, Participants with metastases to the brain stem, midbrain, pons, medulla, or within 10 millimeters (mm) of the optic apparatus (optic nerves and chiasm) are excluded
  • History of Human Immunodeficiency Virus (HIV)
  • Participants with active hepatitis B, active hepatitis C, or active tuberculosis
  • Pregnant or lactating women
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: BP29427 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. and Canada)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, New York
[Not yet recruiting]
New York, New York, United States, 10065
United States, Pennsylvania
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19104
Belgium
[Recruiting]
Bruxelles, Belgium, 1200
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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