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

NCT02760797 | Completed Phase 1

• 2 other identifiers: BP294272015-004348-21
• Study Type: interventional
• Target: 38
• Locations: 3 countries
• Sites: 6

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).

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Dose-Limiting Toxicities (DLTs)

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

Secondary Outcomes (39)

• 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

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

Study Arms (2)

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.

Drug: Emactuzumab; Drug: RO7009789

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.

Drug: Emactuzumab; Drug: RO7009789

Interventions

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.

Also known as: RO5509554

Part I (Dose-Finding Stage); Part II (Dose Expansion Stage)

RO7009789 DRUG

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

Part I (Dose-Finding Stage); Part II (Dose Expansion Stage)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Location

University Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

Centre Leon Berard; Departement Oncologie Medicale

Lyon, 69373, France

Location

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, 31059, France

Location

Institut Gustave Roussy; Sitep

Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 33097612 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

emactuzumab; selicrelumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 4, 2016
• Study Start: May 9, 2016
• Primary Completion: April 6, 2018
• Study Completion: April 6, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

US (2); BE (1); FR (3)