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A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

Primary Purpose

Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MCLA-129
Osimertinib
Sponsored by
Merus N.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer Metastatic focused on measuring MCLA-129, EGFR inhibitor, NSCLC, C-MET, GC/GEJ, Head and Neck Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced unresected disease that is incurable.
  • Patients with NSCLC or other solid tumors who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens.
  • Availability of archival or a fresh tumor tissue sample.
  • Measurable disease as defined by RECIST version 1.1 by radiologic methods.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks, as per Investigator.
  • Adequate organ function:

    • Absolute neutrophil count (ANC) ≥1.5 X 109/L
    • Hemoglobin ≥9 g/dL
    • Platelets ≥100 x 109/L
    • Corrected total serum calcium within normal ranges
    • Serum magnesium within normal ranges (or corrected with supplements)
    • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN (patients with Gilbert's syndrome are eligible if conjugated bilirubin value is within normal limits); in cases of liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed
    • Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min calculated according to the Cockcroft and Gault formula or MDRD formula for patients aged >65 years
    • Serum albumin >3.3 g/dL

Exclusion Criteria:

  • Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry.
  • Known leptomeningeal involvement.
  • Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
  • Prior treatment with a bispecific EGFR-c-MET antibody.
  • Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required.
  • Major surgery or radiotherapy within 3 weeks of the first dose of study drug.
  • Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement are allowed.
  • History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents.
  • History of clinically significant cardiovascular disease including, but not limited to:

    • Diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to first dose of study drug, or any of the following within 6 months prior to the first dose of study drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome.
    • Prolonged QT interval > 480 msec or clinically significant cardiac arrythmia or electrophysiologic disease (i.e., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate). Patients with cardiac pacemakers who are clinically stable are eligible.
    • Uncontrolled (persistent) arterial hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 100 mm Hg.
    • Congestive heart failure (CHF) defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF within 6 months of the first dose of study drug.
    • Clinically significant pericardial effusion.
    • Myocarditis.
  • History of interstitial lung disease including drug-induced interstitial lung disease, radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year.
  • Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety and efficacy of the study drug.
  • Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy.
  • Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
  • Active Hepatitis B infection (HBsAg positive) without receiving antiviral treatment.
  • Positive test for Hepatitis C ribonucleic acid (HCV RNA);
  • Known history of HIV (HIV 1/2 antibodies).

Sites / Locations

  • University of California, IrvineRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • START Mountain RegionRecruiting
  • Next Oncology Virginia
  • Institut Jules BordetRecruiting
  • Antwerp University HospitalRecruiting
  • Clinique de l'EuropeRecruiting
  • CHU Hopitaux de Bordeaux - Hôpital Saint-AndréRecruiting
  • Institut BergoniéRecruiting
  • CHU de Lyon - Louis Pradel HospitalRecruiting
  • Centre Hospitalier Intercommunal de CréteilRecruiting
  • Hôpital Albert CalmetteRecruiting
  • L'Institut Paoli - CalmettesRecruiting
  • CHU de Nantes - Hôpital Nord LaennecRecruiting
  • Marie WislezRecruiting
  • Hôpital Bichat - Claude-BernardRecruiting
  • Hôpital Européen Georges Pompidou (HEGP)
  • CHU de PoitiersRecruiting
  • CHU de Rennes - Hôpital PontchaillouRecruiting
  • Hôpital d'Instruction des Armées BéginRecruiting
  • Krankenhaus NordwestRecruiting
  • Sana Klinikum Offenbach GmbH
  • Istituto Nazionale dei Tumori Regina ElenaRecruiting
  • ASST Papa Giovanni XXIII
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
  • ASST degli Spedali Civili di BresciaRecruiting
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga
  • Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
  • Gachon University Gil Hospital
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Netherlands Cancer Institute
  • University Medical Center Groningen
  • Erasmus Medical CenterRecruiting
  • National Cancer Centre of SingaporeRecruiting
  • Hospital HM DelfosRecruiting
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Vall d'HebronRecruiting
  • IOB Institute of Oncology - Hospital Quironsalud BarcelonaRecruiting
  • Hospital General Universitario Gregorio Marañón
  • Clínica Universidad de Navarra -MadridRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Hospital Universitario 12 de Octubre
  • Centro Integral Oncológico Clara CampalRecruiting
  • Hospital Quirón MadridRecruiting
  • Clínica Universidad de NavarraRecruiting
  • Fundación Instituto Valenciano de Oncología (IVO)
  • Hospital Universitari i Politècnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 2 NSCLC harboring EGFR exon 20 Insertion

Part 2 NSCLC harboring cMet exon 14 skipping mutation

Part 2 Select solid tumors harboring an EGFR or cMet driving mutation

Part 2 NSCLC First-line

Part 2 NSCLC Second-line or more

Arm Description

Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).

Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).

Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).

Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.

Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.

Outcomes

Primary Outcome Measures

To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent MCLA-129 in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
To evaluate the ORR of MCLA-129 alone or in combination with Osimertinib in molecularly defined populations of advanced/metastatic solid tumors.

Secondary Outcome Measures

To evaluate preliminary antitumor activity in terms of best overall response (BOR)
To evaluate preliminary antitumor activity in terms of overall response rate (ORR)
To evaluate preliminary antitumor activity in terms of disease control rate (DCR)
To evaluate preliminary antitumor activity in terms of duration of response (DoR).
To evaluate progression-free survival (PFS)
To evaluate overall survival (OS).
Maximum plasma concentration [Cmax]
Plasma concentration at 0 hours [C0h]
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Area under the concentration versus time curve [AUC0-∞]
Time to reach maximum concentration [tmax]
Half-life [t1/2]
To assess changes in cytokines (TNFα) in serum blood following administration of MCLA-129
To assess changes in cytokines (IFNγ) in serum blood following administration of MCLA-129
To assess changes in cytokines (IL-1β) in serum blood following administration of MCLA-129
To assess changes in cytokines (IL-2) in serum blood following administration of MCLA-129
To assess changes in cytokines (IL-6) in serum blood following administration of MCLA-129
Incidence of anti-drug antibodies in serum blood against MCLA-129
Serum titers of anti-drug (MCLA-129) antibodies in serum blood
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Proportion of patient with treatment discontinuations

Full Information

First Posted
April 9, 2021
Last Updated
May 7, 2023
Sponsor
Merus N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04868877
Brief Title
A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
Official Title
Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (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
No

5. Study Description

Brief Summary
A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 as monotherapy in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who have progressed after receiving prior therapy for advanced/metastatic disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer Metastatic, Gastric Cancer, Esophageal Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma
Keywords
MCLA-129, EGFR inhibitor, NSCLC, C-MET, GC/GEJ, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 2 NSCLC harboring EGFR exon 20 Insertion
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
Arm Title
Part 2 NSCLC harboring cMet exon 14 skipping mutation
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
Arm Title
Part 2 Select solid tumors harboring an EGFR or cMet driving mutation
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D).
Arm Title
Part 2 NSCLC First-line
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
Arm Title
Part 2 NSCLC Second-line or more
Arm Type
Experimental
Arm Description
Participants will receive intravenous infusion of MCLA-129 every two weeks at the recommended Phase II dose (RP2D) and Osimertinib orally once daily starting at a dose of 80mg.
Intervention Type
Drug
Intervention Name(s)
MCLA-129
Other Intervention Name(s)
bispecific
Intervention Description
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Intervention Type
Drug
Intervention Name(s)
Osimertinib
Other Intervention Name(s)
Tagrisso
Intervention Description
Approved, 3rd-generation EGFR-TKI
Primary Outcome Measure Information:
Title
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent MCLA-129 in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
Time Frame
First 28 days of treatment
Title
To evaluate the ORR of MCLA-129 alone or in combination with Osimertinib in molecularly defined populations of advanced/metastatic solid tumors.
Time Frame
From first dose until 1 year after end of treatment or initiation of an alternative treatment, whichever occurs first.
Secondary Outcome Measure Information:
Title
To evaluate preliminary antitumor activity in terms of best overall response (BOR)
Time Frame
Every 8 weeks until study ends, approximately 2 years
Title
To evaluate preliminary antitumor activity in terms of overall response rate (ORR)
Time Frame
Every 8 weeks until study ends, approximately 2 years
Title
To evaluate preliminary antitumor activity in terms of disease control rate (DCR)
Time Frame
Every 8 weeks until study ends, approximately 2 years
Title
To evaluate preliminary antitumor activity in terms of duration of response (DoR).
Time Frame
Every 8 weeks until study ends, approximately 2 years
Title
To evaluate progression-free survival (PFS)
Time Frame
Every 8 weeks until study ends, approximately 2 years
Title
To evaluate overall survival (OS).
Time Frame
Every 8 weeks until study ends, approximately 2 years
Title
Maximum plasma concentration [Cmax]
Time Frame
12 months
Title
Plasma concentration at 0 hours [C0h]
Time Frame
12 months
Title
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Time Frame
12 months
Title
Area under the concentration versus time curve [AUC0-∞]
Time Frame
12 months
Title
Time to reach maximum concentration [tmax]
Time Frame
12 months
Title
Half-life [t1/2]
Time Frame
12 months
Title
To assess changes in cytokines (TNFα) in serum blood following administration of MCLA-129
Time Frame
12 months
Title
To assess changes in cytokines (IFNγ) in serum blood following administration of MCLA-129
Time Frame
12 months
Title
To assess changes in cytokines (IL-1β) in serum blood following administration of MCLA-129
Time Frame
12 months
Title
To assess changes in cytokines (IL-2) in serum blood following administration of MCLA-129
Time Frame
12 months
Title
To assess changes in cytokines (IL-6) in serum blood following administration of MCLA-129
Time Frame
12 months
Title
Incidence of anti-drug antibodies in serum blood against MCLA-129
Time Frame
12 months
Title
Serum titers of anti-drug (MCLA-129) antibodies in serum blood
Time Frame
12 months
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
12 months
Title
Proportion of patient with treatment discontinuations
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced unresected disease that is incurable. Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens. Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as determined by the investigator Availability of archival or a fresh tumor tissue sample. Measurable disease as defined by RECIST version 1.1 by radiologic methods. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy ≥ 12 weeks, as per Investigator. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5 X 10^9/L Hemoglobin ≥9 g/dL Platelets ≥100 x 10^9/L Corrected total serum calcium within normal ranges Serum magnesium within normal ranges (or corrected with supplements) Serum potassium within normal ranges Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN (patients with Gilbert's syndrome are eligible if conjugated bilirubin value is within normal limits); in cases of liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min calculated according to the Cockcroft and Gault formula or MDRD formula for patients aged >65 years Serum albumin >3.3 g/dL Exclusion Criteria: Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry. Known leptomeningeal involvement. Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry. Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required. Major surgery or radiotherapy within 3 weeks of the first dose of study drug. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible. Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement are allowed. History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents. History of clinically significant cardiovascular disease including, but not limited to: Diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to first dose of study drug, or any of the following within 6 months prior to the first dose of study drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Prolonged QT interval > 480 msec or clinically significant cardiac arrythmia or electrophysiologic disease (i.e., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate) or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities. Patients with cardiac pacemakers who are clinically stable are eligible. Heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes. Uncontrolled (persistent) arterial hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 100 mm Hg. Congestive heart failure (CHF) defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF within 6 months of the first dose of study drug. Clinically significant pericardial effusion. Myocarditis. History of interstitial lung disease including drug-induced interstitial lung disease, radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year. Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety and efficacy of the study drug. Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders Active Hepatitis B infection (HBsAg positive) without receiving antiviral treatment. Positive test for Hepatitis C ribonucleic acid (HCV RNA); Known history of HIV (HIV 1/2 antibodies).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merus Inquiries
Phone
617-401-4499
Email
USenquiries@merus.nl
Facility Information:
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sai-Hong I Ou
Phone
714-456-8000
First Name & Middle Initial & Last Name & Degree
Sai-Hong I Ou, MD
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Johnson, MD
Phone
212-729-4664
First Name & Middle Initial & Last Name & Degree
Melissa Johnson, MD
Facility Name
START Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Call, MD
Phone
801-509-8520
First Name & Middle Initial & Last Name & Degree
Justin Call, MD
Facility Name
Next Oncology Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Spira, MD, PhD.
Phone
703-280-5390
First Name & Middle Initial & Last Name & Degree
Alex Spira, MD, PhD.
Facility Name
Institut Jules Bordet
City
Anderlecht
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Brandão, MD, PhD
Phone
+ 32 0 2 541 33 64
First Name & Middle Initial & Last Name & Degree
Mariana Brandão, MD, PhD
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Prenen, MD, PhD
Phone
+1 323-821-3646
First Name & Middle Initial & Last Name & Degree
Hans Prenen, MD, PhD
Facility Name
Clinique de l'Europe
City
Amiens
ZIP/Postal Code
80090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Dayen, MD
Phone
+33 3 60 12 52 35
First Name & Middle Initial & Last Name & Degree
Charles Dayen, MD
Facility Name
CHU Hopitaux de Bordeaux - Hôpital Saint-André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amaury Daste, MD
Phone
+33 5 56 79 58 08
First Name & Middle Initial & Last Name & Degree
Amaury Daste, MD
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Italiano, MD, PhD
Phone
+33 0547306088
First Name & Middle Initial & Last Name & Degree
Antoine Italiano, MD, PhD
Facility Name
CHU de Lyon - Louis Pradel Hospital
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Duruisseaux, MD
Phone
+33 4 27 85 77 00
First Name & Middle Initial & Last Name & Degree
Michael Duruisseaux, MD
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Monnet, MD
First Name & Middle Initial & Last Name & Degree
Isabelle Monnet, MD
Facility Name
Hôpital Albert Calmette
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Jamme, MD
Phone
+33 3 20 44 59 62
First Name & Middle Initial & Last Name & Degree
Philippe Jamme, MD
Facility Name
L'Institut Paoli - Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Vicier, MD, PhD
Phone
+33 4 91 22 38 94
First Name & Middle Initial & Last Name & Degree
Cecile Vicier, MD, PhD
Facility Name
CHU de Nantes - Hôpital Nord Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Bordenave, MD
Phone
+33 0240165930
First Name & Middle Initial & Last Name & Degree
Stephanie Bordenave, MD
Facility Name
Marie Wislez
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Wislez, MD
Phone
+33158411889
First Name & Middle Initial & Last Name & Degree
Marie Wislez, MD
Facility Name
Hôpital Bichat - Claude-Bernard
City
Paris
ZIP/Postal Code
75877
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerard Zalcman, MD, PhD
Phone
+33 1 40 25 74 67
First Name & Middle Initial & Last Name & Degree
Gerard Zalcman, MD, PhD
Facility Name
Hôpital Européen Georges Pompidou (HEGP)
City
Paris
ZIP/Postal Code
75908
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Medioni, MD, PhD
Phone
+33 1 56 09 27 81
First Name & Middle Initial & Last Name & Degree
Jacques Medioni, MD, PhD.
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Isambert, MD
First Name & Middle Initial & Last Name & Degree
Nicolas Isambert, MD
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herve Lena, MD
Phone
+33 2 99 28 24 81
First Name & Middle Initial & Last Name & Degree
Herve Lena, MD
Facility Name
Hôpital d'Instruction des Armées Bégin
City
Saint-Mandé
ZIP/Postal Code
94163
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole Helissey, MD
First Name & Middle Initial & Last Name & Degree
Carole Helissey, MD
Facility Name
Krankenhaus Nordwest
City
Frankfurt am Main
State/Province
Hesse
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Goetze, MD
Phone
+49 69 7601 3128
First Name & Middle Initial & Last Name & Degree
Thorsten Goetze, MD
Facility Name
Sana Klinikum Offenbach GmbH
City
Offenbach am Main
ZIP/Postal Code
63069
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Wehler, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Thomas Wehler, MD, PhD.
Facility Name
Istituto Nazionale dei Tumori Regina Elena
City
Roma
State/Province
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Capuzzo, MD
Phone
+39 0652665698
First Name & Middle Initial & Last Name & Degree
Federico Capuzzo, MD
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Intagliata, MD
First Name & Middle Initial & Last Name & Degree
Salvatore Intagliata, MD
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Ardizzoni, MD
First Name & Middle Initial & Last Name & Degree
Andrea Ardizzoni, MD
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Bossi, MD
Phone
+39 0303996536
First Name & Middle Initial & Last Name & Degree
Paolo Bossi, MD
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
22162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Siena, MD
Phone
+39 0264442409
First Name & Middle Initial & Last Name & Degree
Salvatore Siena, MD
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo De Braud
Phone
+39 02 23903066
First Name & Middle Initial & Last Name & Degree
Filippo De Braud
Facility Name
AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fortunato Ciardiello, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Fortunato Ciardiello, MD, PhD.
Facility Name
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Novello, MD, PhD.
Phone
+39 0119026233
First Name & Middle Initial & Last Name & Degree
Silvia Novello, MD, PhD.
Facility Name
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Pepe, MD, PhD.
Phone
+39 089695371
First Name & Middle Initial & Last Name & Degree
Stefano Pepe, MD, PhD
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Melisi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Davide Melisi, MD, PhD
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Kyung Ahn, MD, MS
First Name & Middle Initial & Last Name & Degree
Hee Kyung Ahn, MD, MS
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se-Hoon Lee, MD, PhD
Phone
+82-2-3410-6856
First Name & Middle Initial & Last Name & Degree
Se-Hoon Lee, MD, PhD
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Hyoung Kang, MD, PhD.
Phone
+82-2-2258-5745
First Name & Middle Initial & Last Name & Degree
Jin-Hyoung Kang, MD, PhD
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon, Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byoung-Yong Shim, MD, PhD.
Phone
+82-31-249-8016
First Name & Middle Initial & Last Name & Degree
Byoung-Yong Shim, MD, PhD.
Facility Name
Netherlands Cancer Institute
City
Amsterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frans Opdam, MD
Phone
+31 (0)20 512 9111
First Name & Middle Initial & Last Name & Degree
Frans Opdam, MD
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthonie Van Der Wekken, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anthonie Van Der Wekken, MD, PhD
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Dingemans, MD, PhD.
Phone
+31 10 703 03 23
First Name & Middle Initial & Last Name & Degree
Anne-Marie Dingemans, MD, PhD.
Facility Name
National Cancer Centre of Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justina Lam
Phone
6564368176
First Name & Middle Initial & Last Name & Degree
Justina Lam
Facility Name
Hospital HM Delfos
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Hernandez Guerrero, MD
Phone
+34 932 54 50 30
First Name & Middle Initial & Last Name & Degree
Tatiana Hernandez Guerrero, MD
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgia Anguera Palacios, MD
First Name & Middle Initial & Last Name & Degree
Georgia Anguera Palacios, MD
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enriqueta Felip, MD, PhD
Phone
+34 932746085
First Name & Middle Initial & Last Name & Degree
Enriqueta Felip, MD, PhD
Facility Name
IOB Institute of Oncology - Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabricio Racca, MD
Phone
+34 93 238 16 61
First Name & Middle Initial & Last Name & Degree
Fabricio Racca, MD
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Calles, MD
Phone
+34 91 586 82 52
First Name & Middle Initial & Last Name & Degree
Antonio Calles, MD
Facility Name
Clínica Universidad de Navarra -Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Fernandez de Sanmamed Gutiérrez, MD, PhD
Phone
+34 913531920
First Name & Middle Initial & Last Name & Degree
Miguel Fernandez de Sanmamed Gutiérrez, MD, PhD
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Moreno Garcia, MD, PhD
Phone
+34 915504800
Ext
2805
First Name & Middle Initial & Last Name & Degree
Victor Moreno Garcia, MD, PhD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Paz-Ares Rodriguez, MD, PhD
First Name & Middle Initial & Last Name & Degree
Luis Paz-Ares Rodriguez, MD, PhD
Facility Name
Centro Integral Oncológico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Moreno Candilejo, MD
Phone
+34 917567825
First Name & Middle Initial & Last Name & Degree
Irene Moreno Candilejo, MD
Facility Name
Hospital Quirón Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Boni, MD, PhD
Phone
+34 914 52 19 00
First Name & Middle Initial & Last Name & Degree
Valentina Boni, MD, PhD
Facility Name
Clínica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Fernandez de Sanmamed Gutiérrez, MD, PhD
Phone
+34 848428428
First Name & Middle Initial & Last Name & Degree
Miguel Fernandez de Sanmamed Gutiérrez, MD, PhD
Facility Name
Fundación Instituto Valenciano de Oncología (IVO)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Gil-Bazo, MD, PhD
Phone
+34 961114000
First Name & Middle Initial & Last Name & Degree
Ignacio Gil-Bazo, MD, PhD.
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Jose Juan Vidal, MD, PhD.
First Name & Middle Initial & Last Name & Degree
Óscar Jose Juan Vidal, MD, PhD.

12. IPD Sharing Statement

Learn more about this trial

A Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

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