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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004348-21 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I (Dose-Finding Stage) | Experimental | 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. |
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| Part II (Dose Expansion Stage) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | Up to 6 weeks from Day (D) 1 of Cycle (C) 1 (cycle = 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Emactuzumab | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | United States | |||
| University Pennsylvania Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33097612 | Derived | 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, Ruttinger 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):e001153. doi: 10.1136/jitc-2020-001153. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000602304 | emactuzumab |
| C518149 | selicrelumab |
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| RO7009789 | Drug | RO7009789 will be administered IV every 3 weeks (every cycle). |
|
| 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 | 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) | PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details |
| Serum Trough Concentration (Ctrough) of Emactuzumab | 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 | 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) | PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details |
| Total Clearance (CL) of Emactuzumab | 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) | PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details |
| Volume of Distribution at Steady State (Vss) of Emactuzumab | 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) | PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details |
| Accumulation Ratio of Emactuzumab | 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) | PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details |
| Terminal Elimination Half-Life (T1/2) of Emactuzumab | 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) | PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details |
| Concentration at Time of Tumor Progression (Cprog) of Emactuzumab According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 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 | At time of tumor response (up to 2 years) |
| Concentration of Emactuzumab at Time of Infusion-Related Reaction (IRR) or Hypersensitivity Reaction | At time of IRR or hypersensitivity reaction (up to 2 years) |
| Cmax of RO7009789 | 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 | PrD (0 H) on D1 of C2 onwards (cycle = 3 weeks) until PD (up to 2 years) |
| AUC of RO7009789 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline; on D1 of C2 (cycle = 3 weeks); and optionally at time of PD (up to 2 years) |
| Levels of Functional Tumor-Infiltrating Lymphocytes | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From Baseline until death or PD; assessed every 6 weeks (up to 2 years overall) |
| Duration of Response (DOR) as Assessed by Modified RECIST | From OR until PD; assessed every 6 weeks (up to 2 years overall) |
| Percentage of Participants with Clinical Benefit as Assessed by Modified RECIST | Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall) |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Institut Gustave Roussy; Sitep | Villejuif | 94805 | France |