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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Hoffmann-La Roche
Study ID
NCT02323191
Phase
PHASE1
Status
Completed

Conditions

  • Solid Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Participants will receive atezolizumab intravenously at a fixed dose of 1200 milligram (mg) q3w.
  • Emactuzumab — DRUG
    Participants will receive emactuzumab intravenously in ascending dose levels with a starting dose of 500 mg.

Study Details

This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment. Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.

Key Dates

Start date
Jan 19, 2015
Status verified
Aug 2020
Primary completion
Aug 21, 2020
Completion
Aug 21, 2020

Study Design

Enrollment
221 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Dose-finding): Emactuzumab + Atezolizumab
    Participants will receive escalating doses of emactuzumab along with atezolizumab every 3 weeks (q3w).
  • Experimental: Part 2 (Expansion): Emactuzumab + Atezolizumab
    Participants will receive emactuzumab at or below the MTDs for the combination treatments that are determined during Part 1 along with atezolizumab.

Primary Outcome Measure

Percentage of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Yale Cancer Center; Medical OncologyNew HavenConnecticut06520-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber - HarvardBostonMassachusetts--
Massachusetts General Hospital.BostonMassachusetts02114-
Memorial Sloan-Kettering Cancer Center Breast & Imaging CenterNew YorkNew York10065-

Find similar trials in New Haven, CT

By research site
Yale Cancer Center; Medical Oncology· New Haven, CTBeth Israel Deaconess Medical Center· Boston, MADana Farber - Harvard· Boston, MAMassachusetts General Hospital.· Boston, MAMemorial Sloan-Kettering Cancer Center Breast & Imaging Center· New York, NY

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