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Completed

NCT Number: NCT02760797

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

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).

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cliniques Universitaires St-Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emactuzumab

Drug

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 names: RO5509554

RO7009789

Drug

RO7009789 will be administered IV every 3 weeks (every cycle).

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. Ctrough of RO7009789

    Time frame: PrD (0 H) on D1 of C2 onwards (cycle = 3 weeks) until PD (up to 2 years)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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)

  30. 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)

  31. 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)

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. 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)

  37. 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)

  38. Duration of Response (DOR) as Assessed by Modified RECIST

    Time frame: From OR until PD; assessed every 6 weeks (up to 2 years overall)

  39. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 4, 2016
Registry last updated
May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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