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NeoplasmsPhase 1NCT02760797

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

A Phase 1 study testing Emactuzumab and RO7009789 in people with Neoplasms, run by Hoffmann-La Roche at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Emactuzumab and RO7009789
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
6 sitesin 3 countries
Study dates
9 May 2016to 6 Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

France3 sites

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Institut Gustave Roussy; Sitep

    Villejuif, 94805

Other trials in France

United States2 sites

  • Memorial Sloan-Kettering Cancer Center

    New York, New York

  • University Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Belgium1 site

  • Cliniques Universitaires St-Luc

    Brussels, 1200

Other trials in Belgium

About this study

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

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).

Conditions
Neoplasms
Being tested
Emactuzumab, RO7009789
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmactuzumabDrug

    Also called RO5509554

    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.

  • RO7009789Drug

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

Study groups in NCT02760797
Study groupRoleWhat they receive
Part I (Dose-Finding Stage)ExperimentalEmactuzumab 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.
Receives: Drug: Emactuzumab; Drug: RO7009789
Part II (Dose Expansion Stage)ExperimentalEmactuzumab 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.
Receives: Drug: Emactuzumab; Drug: RO7009789

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Dose-Limiting Toxicities (DLTs)

    Measured: Up to 6 weeks from Day (D) 1 of Cycle (C) 1 (cycle = 3 weeks)

Secondary outcomes (39)

  1. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Emactuzumab

    Measured: 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

    Measured: 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

    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)

    Measured: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details

  4. Serum Trough Concentration (Ctrough) of Emactuzumab

    Measured: 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

    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)

    Measured: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details

  6. 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)

    Measured: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details

  7. 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)

    Measured: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details

  8. 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)

    Measured: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details

  9. 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)

    Measured: PrD (0 H) D1 of C1 up to 120 days after last dose (up to 2 years overall); see Outcome Measure Description for details

  10. Concentration at Time of Tumor Progression (Cprog) of Emactuzumab According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

    Measured: 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

    Measured: At time of tumor response (up to 2 years)

  12. Concentration of Emactuzumab at Time of Infusion-Related Reaction (IRR) or Hypersensitivity Reaction

    Measured: At time of IRR or hypersensitivity reaction (up to 2 years)

  13. Cmax of RO7009789

    Measured: 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

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

  15. AUC of RO7009789

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline; every 6 weeks until PD (up to 2 years); at 28 days after last dose (up to 2 years overall)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study start9 May 2016
  3. Primary completion6 Apr 2018
  4. Study completion6 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760797
Sponsor's protocol ID
BP29427
Other IDs
2015-004348-21, 2015
Status last verified
May 2018
First submitted
14 Apr 2016
Last updated
22 May 2018
Results posted
No

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, 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.

    PubMed 33097612

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Emactuzumab and RO7009789 in people with Neoplasms, run by Hoffmann-La Roche at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.

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