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A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

Primary Purpose

Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
zenocutuzumab (MCLA-128)
Sponsored by
Merus N.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumours Harboring NRG1 Fusion focused on measuring Bispecific Antibody IgG1, HER2, HER3, MCLA-128, Antibodies, Bispecific, Immunologic Factors, NRG1 fusion, NRG1, Solid tumor, Pancreatic cancer, PDAC, Non-small cell lung cancer, NSCLC, zenocutuzumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 10) in Group H;
  • Performance status of ECOG 0 - 2;
  • Estimated life expectancy of at least 12 weeks;
  • Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade 1;
  • Treatment with anti-cancer medication or investigational drugs within the following intervals before the first dose of MCLA-128:

    1. >14 days or >5 half-lives prior to study entry, whichever is shorter.
    2. >14 days for radiotherapy.
  • Recovery from major surgery or other complication to ≤ Grade 2 or baseline ;
  • Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support for at least 7 days prior to screening;
  • Platelets ≥100 x 109/L without transfusion support for at least 7 days prior to screening;
  • Hemoglobin ≥8 g/dL or ≥5 mmol/L;
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN; in cases of metastatic liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed; in cases of antecedents of Gilbert's syndrome when total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN will be allowed;
  • Estimated glomerular filtration rate (GFR) of >30 mL/min
  • Able to provide a tumor biopsy sample (fresh strongly preferred or else archival);
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 month after completion of study therapy;
  • Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy or no satisfactory alternative treatment options are available;
  • Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other similarly-certified laboratories.

Exclusion Criteria:

  • Pregnant or lactating;
  • Presence of an active uncontrolled infection or an unexplained fever;
  • Known hypersensitivity to any of the components of MCLA-128;
  • Known HIV, active Hepatitis B without receiving antiviral treatment, or Hepatitis C; patients treated for Hepatitis C and have undetectable viral loads are eligible
  • Known symptomatic or unstable brain metastases;
  • Patients with leptomeningeal metastases
  • Presence of congestive heart failure or Left Ventricular Ejection Fraction<50% or history of significant cardiac disease, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication.
  • Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or carcinoma in situ of the uterine cervix) unless the tumor was treated with curative intent more than 2 years prior to study entry;
  • Presence of any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.

Sites / Locations

  • Mayo ClinicRecruiting
  • University of California IrvineRecruiting
  • Stanford UniversityRecruiting
  • Georgetown UniversityRecruiting
  • Cancer Specialists of North FloridaRecruiting
  • Mayo ClinicRecruiting
  • Emory Winship Cancer InstituteRecruiting
  • Dana Farber Cancer CenterRecruiting
  • Karmanos Cancer CenterRecruiting
  • Mayo ClinicRecruiting
  • Billings Clinic Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of PennsylvaniaRecruiting
  • Averra Medical GroupRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Huntsman Cancer InstituteRecruiting
  • Utah Cancer SpecialistsRecruiting
  • Hematology-Oncology Specialist of FredericksburgRecruiting
  • Virginia Mason Hospital & Seattle Medical CenterRecruiting
  • Hematology Oncology AssociatesRecruiting
  • Northwest Medical SpecialtiesRecruiting
  • Salzburger UniversitatsklinikumRecruiting
  • UZ LeuvenRecruiting
  • Princess MargaretCancer CentreRecruiting
  • Centre Leon BerardRecruiting
  • Hospital Louis Pradel, FRRecruiting
  • Institut Gustave RoussyRecruiting
  • Hopital CochinRecruiting
  • Hopital CurieRecruiting
  • Asklepios Klinik AltonaRecruiting
  • Asklepios Kliniken Hamburg GmbHRecruiting
  • Deutsches KrebsforschungszentrumRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Ospedale San RaffaeleRecruiting
  • Niguarda Cancer CentreRecruiting
  • Istituti Fisioterapici OspitalieriRecruiting
  • National Cancer Center HospitalRecruiting
  • St. Marianna University School of Medicine HospitalRecruiting
  • Osaka International Cancer InstituteRecruiting
  • National Cancer Center EastRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University College of MedicineRecruiting
  • Severance Hospital- Yonsei Cancer CenterRecruiting
  • NKIRecruiting
  • Amsterdam Medical CenterRecruiting
  • Radboud University Medical CenterRecruiting
  • UMC UtrechtRecruiting
  • University Hospital OsloRecruiting
  • National Cancer Centre of Singapore PTE LTDRecruiting
  • Vall D'Hebron Institute of Oncology (VHIO)Recruiting
  • START Hospital Fundación Jiménez DiazRecruiting
  • START Hospital Universitario Madrid SanchinarroRecruiting
  • Hospital 12 de OctubreRecruiting
  • Clínica Universidad de NavarraRecruiting
  • Instituto Valenciano OncologiaRecruiting
  • Karolinska UniversitetssjukhusetRecruiting
  • National Taiwan University Hospital 7Recruiting
  • Sarah Cannon Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion

Part 2 NSCLC cancer harboring NRG1 fusion

Part 2 Solid tumour (basket) harboring NRG1 fusion

Arm Description

Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.

Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.

Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.

Outcomes

Primary Outcome Measures

Objective overall response rate (ORR) as per local investigator's assessment
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR)
Duration of response per RECIST v1.1 as per local Investigator's assessment.
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally

Secondary Outcome Measures

Maximum plasma concentration [Cmax]
Assess the Cmax of zenocutuzumab (MCLA-128)
Volume of distribution [V]
Assess the volume of distribution of zenocutuzumab (MCLA-128)
Volume of distribution at steady state [Vss]
Assess the volume of distribution of zenocutuzumab (MCLA-128) at steady state
half-life [t1/2]
Assess the half-life of zenocutuzumab (MCLA-128)
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Assess the Area under the concentration versus time curve from time zero to time t [AUC0-t] of zenocutuzumab (MCLA-128)
area under the concentration versus time curve [AUC0-∞]
Assess the area under the concentration versus time curve [AUC0-∞] of zenocutuzumab (MCLA-128)
time to reach maximum concentration [tmax]
Assess the time to reach maximum concentration [tmax] of zenocutuzumab (MCLA-128)
Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
Assess the Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
serum titers of anti-drug antibodies
Assess serum titers of anti-drug antibodies
Overall response rate as per central review
Assess the anti-tumor response of zenocutuzumab (MCLA-128) by RECIST v1.1 as assessed centrally
Clinical Benefit Rate (CBR) of zenocutuzumab (MCLA-128) assessed locally and centrally
CBR assessed as the proportion of patients in whom a complete response (CR) or partial response (PR) or stable disease (SD) is observed (where SD duration is a minimum of 12 weeks) by RECIST v1.1 .
Duration of Response as per central review
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed centrally
Time to response per RECIST v1.1. as per local Investigator's assessment.
To assess time to onset of response in patients with NRG1 fusions as assessed locally
Time to response per RECIST v1.1. as per central review
To assess time to onset of response in patients with NRG1 fusions as assessed centrally
Characterize the safety and tolerability of zenocutuzumab (MCLA-128)
Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE)
Evaluation of progression free survival (PFS)
Evaluation of overall survival (OS)

Full Information

First Posted
August 16, 2016
Last Updated
December 23, 2022
Sponsor
Merus N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT02912949
Brief Title
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
Official Title
A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merus N.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)
Detailed Description
Study Design : This open label (all participants know the identity of the study drug), multicenter (more than one study site), first-in-human study consisting of 2 parts. Part 1 is a dose escalation and Part 2 is a dose expansion cohort. Part 1 has been completed. Part 2 new patient populations examined: Group F: Patients with NSCLC with documented NRG1 fusion Group G: Patients with pancreatic adenocarcinoma with documented NRG1 fusion Group H: Patients with any other solid tumor with documented NRG1 fusion For these new patient populations, Part 2 will further characterize the safety and tolerability of the selected dose level of zenocutuzumab (MCLA-128), as well as assessment of CBR, defined as the proportion of patients with a CR, PR or durable SD (SD for at least 12 weeks in duration). For the new patient populations, overall response rate (ORR) and duration of response (DOR) will be described. The study consists of 3 periods: Screening period (up to 28 days prior to the first dose of study drug); Treatment period (treatment cycles of 28 days); and Follow Up period (through 30 days after the last dose and quarterly checks for survival data for up to 2 years). Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion, NRG1 Fusion
Keywords
Bispecific Antibody IgG1, HER2, HER3, MCLA-128, Antibodies, Bispecific, Immunologic Factors, NRG1 fusion, NRG1, Solid tumor, Pancreatic cancer, PDAC, Non-small cell lung cancer, NSCLC, zenocutuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Arm Title
Part 2 NSCLC cancer harboring NRG1 fusion
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Arm Title
Part 2 Solid tumour (basket) harboring NRG1 fusion
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
zenocutuzumab (MCLA-128)
Other Intervention Name(s)
bispecific, MCLA-128
Intervention Description
full length IgG1 bispecific antibody targeting HER2 and HER3
Primary Outcome Measure Information:
Title
Objective overall response rate (ORR) as per local investigator's assessment
Description
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR)
Time Frame
36 months
Title
Duration of response per RECIST v1.1 as per local Investigator's assessment.
Description
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally
Time Frame
36 Months
Secondary Outcome Measure Information:
Title
Maximum plasma concentration [Cmax]
Description
Assess the Cmax of zenocutuzumab (MCLA-128)
Time Frame
36 months
Title
Volume of distribution [V]
Description
Assess the volume of distribution of zenocutuzumab (MCLA-128)
Time Frame
36 months
Title
Volume of distribution at steady state [Vss]
Description
Assess the volume of distribution of zenocutuzumab (MCLA-128) at steady state
Time Frame
36 months
Title
half-life [t1/2]
Description
Assess the half-life of zenocutuzumab (MCLA-128)
Time Frame
36 months
Title
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Description
Assess the Area under the concentration versus time curve from time zero to time t [AUC0-t] of zenocutuzumab (MCLA-128)
Time Frame
36 months
Title
area under the concentration versus time curve [AUC0-∞]
Description
Assess the area under the concentration versus time curve [AUC0-∞] of zenocutuzumab (MCLA-128)
Time Frame
36 months
Title
time to reach maximum concentration [tmax]
Description
Assess the time to reach maximum concentration [tmax] of zenocutuzumab (MCLA-128)
Time Frame
36 months
Title
Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
Description
Assess the Incidence of anti-drug antibodies against zenocutuzumab (MCLA-128)
Time Frame
36 months
Title
serum titers of anti-drug antibodies
Description
Assess serum titers of anti-drug antibodies
Time Frame
36 months
Title
Overall response rate as per central review
Description
Assess the anti-tumor response of zenocutuzumab (MCLA-128) by RECIST v1.1 as assessed centrally
Time Frame
36 months
Title
Clinical Benefit Rate (CBR) of zenocutuzumab (MCLA-128) assessed locally and centrally
Description
CBR assessed as the proportion of patients in whom a complete response (CR) or partial response (PR) or stable disease (SD) is observed (where SD duration is a minimum of 12 weeks) by RECIST v1.1 .
Time Frame
36 months
Title
Duration of Response as per central review
Description
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed centrally
Time Frame
36 months
Title
Time to response per RECIST v1.1. as per local Investigator's assessment.
Description
To assess time to onset of response in patients with NRG1 fusions as assessed locally
Time Frame
36 months
Title
Time to response per RECIST v1.1. as per central review
Description
To assess time to onset of response in patients with NRG1 fusions as assessed centrally
Time Frame
36 months
Title
Characterize the safety and tolerability of zenocutuzumab (MCLA-128)
Description
Number of participants with Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame
6-12 months
Title
Evaluation of progression free survival (PFS)
Time Frame
36 months
Title
Evaluation of overall survival (OS)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 10) in Group H; Performance status of ECOG 0 - 2; Estimated life expectancy of at least 12 weeks; Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade 1; Treatment with anti-cancer medication or investigational drugs within the following intervals before the first dose of MCLA-128: >14 days or >5 half-lives prior to study entry, whichever is shorter. >14 days for radiotherapy. Recovery from major surgery or other complication to ≤ Grade 2 or baseline ; Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support for at least 7 days prior to screening; Platelets ≥100 x 109/L without transfusion support for at least 7 days prior to screening; Hemoglobin ≥8 g/dL or ≥5 mmol/L; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN; in cases of metastatic liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed; in cases of antecedents of Gilbert's syndrome when total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN will be allowed; Estimated glomerular filtration rate (GFR) of >30 mL/min Able to provide a tumor biopsy sample (fresh strongly preferred or else archival); Not pregnant or nursing Fertile patients must use effective contraception during and for 6 month after completion of study therapy; Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy or no satisfactory alternative treatment options are available; Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other similarly-certified laboratories. Exclusion Criteria: Pregnant or lactating; Presence of an active uncontrolled infection or an unexplained fever; Known hypersensitivity to any of the components of MCLA-128; Known HIV, active Hepatitis B without receiving antiviral treatment, or Hepatitis C; patients treated for Hepatitis C and have undetectable viral loads are eligible Known symptomatic or unstable brain metastases; Patients with leptomeningeal metastases Presence of congestive heart failure or Left Ventricular Ejection Fraction<50% or history of significant cardiac disease, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication. Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or carcinoma in situ of the uterine cervix) unless the tumor was treated with curative intent more than 2 years prior to study entry; Presence of any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merus Inquiries
Phone
1-833-NRG-1234
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Schram, MD
Organizational Affiliation
Memorial Sloan Kettering Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trials referrals office
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Tanios Bekaii-Saab, MD
Facility Name
University of California Irvine
City
Irvine
State/Province
California
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignatius Ou, MD
Phone
877-827-8839
First Name & Middle Initial & Last Name & Degree
Ignatius Ou, MD
Facility Name
Stanford University
City
Palo Alto
State/Province
California
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivaani Kummar, MD
Phone
877-827-8839
First Name & Middle Initial & Last Name & Degree
Shivaani Kummar, MD
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Liu, MD
Phone
202-687-9861
First Name & Middle Initial & Last Name & Degree
Stephen Liu, MD
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
904-538-4488
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trials referral office
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Jason Starr
Facility Name
Emory Winship Cancer Institute
City
Atlanta
State/Province
Georgia
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-778-0032
Facility Name
Dana Farber Cancer Center
City
Boston
State/Province
Massachusetts
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Cleary, MD
Phone
617-632-6623
First Name & Middle Initial & Last Name & Degree
James Cleary, MD
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaclyn Ventimiglia
Phone
313-576-9813
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trials referral office
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Wen Wee Ma, MD
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
406-238-2500
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Schram, MD
Phone
646-888-4226
First Name & Middle Initial & Last Name & Degree
Alison Schram
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-220-9711
Facility Name
Averra Medical Group
City
Sioux Falls
State/Province
South Dakota
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
605-322-3295
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Rodon, MD
Phone
713-563-1930
First Name & Middle Initial & Last Name & Degree
Jordi Rodon
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-587-7000
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-270-2243
Facility Name
Hematology-Oncology Specialist of Fredericksburg
City
Fredericksburg
State/Province
Virginia
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
540-371-0079
Facility Name
Virginia Mason Hospital & Seattle Medical Center
City
Seattle
State/Province
Washington
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
206-223-6193
Facility Name
Hematology Oncology Associates
City
Spokane
State/Province
Washington
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Staff
Phone
509-462-2273
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Sandefur
Phone
253-380-5299
Email
ssandefur@nwmsonline.com
Facility Name
Salzburger Universitatsklinikum
City
Salzburg
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Greil, MD
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric van Cutsem, MD
Facility Name
Princess MargaretCancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malcolm Moore, MD
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle De La Fouchardiere, MD
Facility Name
Hospital Louis Pradel, FR
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Duruisseaux, MD
First Name & Middle Initial & Last Name & Degree
Michael Duruisseaux, MD
Facility Name
Institut Gustave Roussy
City
Paris
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elodie Zedouard
First Name & Middle Initial & Last Name & Degree
Patricia Martin-Romano, MD
Facility Name
Hopital Cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Wislez, MD
Facility Name
Hopital Curie
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Neuzillet, MD
Facility Name
Asklepios Klinik Altona
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Arnold, MD
Facility Name
Asklepios Kliniken Hamburg GmbH
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claas Wesseler, MD
Facility Name
Deutsches Krebsforschungszentrum
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Springfeld, MD
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nir Peled, MD
Facility Name
Sheba Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talia Golan, MD
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Reni, MD
Facility Name
Niguarda Cancer Centre
City
Milan
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Siena, Prof
First Name & Middle Initial & Last Name & Degree
Giovanna Marrapese
First Name & Middle Initial & Last Name & Degree
Salvatore Siena, Prof
Facility Name
Istituti Fisioterapici Ospitalieri
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Cappuzzo, MD
Facility Name
National Cancer Center Hospital
City
Chuo-Ku
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chigusa Morizane, MD
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kumiko Umemoto, MD
Facility Name
Osaka International Cancer Institute
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazumi Nishino, MD
Facility Name
National Cancer Center East
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koichi Goto, MD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Oh Park, MD
Facility Name
Seoul National University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Dong-Wan, MD
First Name & Middle Initial & Last Name & Degree
Kim Dong-Wan, MD
Facility Name
Severance Hospital- Yonsei Cancer Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Young Rha, MD
Facility Name
NKI
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frans Opdam, MD
Facility Name
Amsterdam Medical Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanneke Wilmink, MD
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henk Verheul, MD
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellis van Liempt
Phone
+31887569057
Email
oncology-trialssecretariat@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Eelke Gort, MD
Facility Name
University Hospital Oslo
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tormod Guren, Dr.
Facility Name
National Cancer Centre of Singapore PTE LTD
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Shao Weng, MD
First Name & Middle Initial & Last Name & Degree
Justina Lam, MD
Facility Name
Vall D'Hebron Institute of Oncology (VHIO)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabet Tebe
Email
hclinicaltrials@gmail.com
First Name & Middle Initial & Last Name & Degree
Teresa Macarulla, MD
Facility Name
START Hospital Fundación Jiménez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Armellini
First Name & Middle Initial & Last Name & Degree
Victor Moreno, Dr.
Facility Name
START Hospital Universitario Madrid Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Ordoñez
First Name & Middle Initial & Last Name & Degree
Irene Moreno, Dr.
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Paz-Ares, MD
First Name & Middle Initial & Last Name & Degree
Luis Paz-Ares, MD
Facility Name
Clínica Universidad de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Gil-Bazo, MD
Facility Name
Instituto Valenciano Oncologia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desamparados Roda, MD
Facility Name
Karolinska Universitetssjukhuset
City
Solna
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Yachnin, MD
Facility Name
National Taiwan University Hospital 7
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Yang Chih-Hsin, MD
First Name & Middle Initial & Last Name & Degree
James Yang Chih-Hsin
Facility Name
Sarah Cannon Research Institute
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Fontana, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.nrg1.com
Description
For more information about MCLA-128 and the MCLA-128-CL01 study

Learn more about this trial

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

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