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CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Primary Purpose

Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CAB-ROR2-ADC
PD-1 inhibitor
Sponsored by
BioAtla, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
  • Patients must have measurable disease.
  • For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
  • Age ≥ 18 years.
  • Adequate renal function
  • Adequate liver function
  • Adequate hematological function
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least three months.

Exclusion Criteria:

  • Patients must not have clinically significant cardiac disease.
  • Patients must not have known non-controlled CNS metastasis.
  • Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study.
  • Patients must not have had major surgery within 4 weeks before first BA3021 administration.
  • Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
  • Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  • Patients must not be women who are pregnant or breast feeding.

Sites / Locations

  • University of Arizona Cancer Center
  • City of Hope - DuarteRecruiting
  • University of California, San Diego (UCSD) - Moores Cancer CenterRecruiting
  • California Research InstituteRecruiting
  • USC NorrisRecruiting
  • UC Irvine Medical Center - Chao Family Comprehensive Cancer CenterRecruiting
  • University of California San FranciscoRecruiting
  • American Institute of Research
  • University of ColoradoRecruiting
  • Sarah Cannon Research Institute at Health OneRecruiting
  • Florida Cancer Specialists & Research InstituteRecruiting
  • Florida Cancer Specialists & Research InstituteRecruiting
  • Memorial Cancer Institute (MCI)
  • Florida Cancer Specialist - NorthRecruiting
  • Memorial Sloan-Kettering Cancer Center
  • Moffitt Cancer CenterRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Augusta University - Georgia Cancer CenterRecruiting
  • Baptist Health Systems
  • University of KentuckyRecruiting
  • Norton Cancer Institute, Brownsboro Hospital CampusRecruiting
  • Hematology/Oncology ClinicRecruiting
  • Dana-Farber Cancer Institute
  • Comprehensive Cancer Care of Nevada
  • OptumCare Cancer Care
  • Roswell ParkRecruiting
  • NYU Langone HealthRecruiting
  • Columbia University Medical Center
  • FirstHealth Outpatient Cancer CenterRecruiting
  • Wake Forest Baptist Health
  • The Christ HospitalRecruiting
  • Oregon Health & Science University
  • UPMC Cancer CenterRecruiting
  • Medical University of South Carolina- Hollings Cancer CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • Mary Crowley Cancer ResearchRecruiting
  • MD Anderson Cancer CenterRecruiting
  • University of Utah - Huntsman Cancer InstituteRecruiting
  • Norman Golchert
  • Jeanette Natschke
  • Thea Resch
  • Asklepios Clinical Center Harburg
  • HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials UnitRecruiting
  • "Sotiria" Chest Diseases Hospital of Athens, 3rd Department of Internal Medicine of University of Athens, Oncology Unit
  • Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology DepartmentRecruiting
  • Bioclinic Thessaloniki, Οncology DepartmentRecruiting
  • European Interbalkan Medical Center, Οncology DepartmentRecruiting
  • Prince of Wales HospitalRecruiting
  • Queen Mary HospitalRecruiting
  • Santa Maria delle Croci Hospital of Ravenna
  • "IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
  • Polish Mother's Memorial Hospital-Research InstituteRecruiting
  • Beata GłogowskaRecruiting
  • Institute of Genetics and Immunology GENIM LCC in LublinRecruiting
  • Malgorzata KozlikRecruiting
  • MED-Polonia, Sp. z o.o. (LLC)Recruiting
  • University Hospital Nuestra Senora de ValmeRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital del MarRecruiting
  • Anna Ramos LunaRecruiting
  • University Clinic of Navarra - Madrid
  • University Hospital 12 de OctubreRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • LinKou Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Monotherapy - CAB-ROR2-ADC (BA3021) alone

Combination Therapy

Arm Description

BA3021 alone Q2W dosing regimen

CAB-ROR2-ADC (BA3021) with PD-1 inhibitor

Outcomes

Primary Outcome Measures

Phase 1: Safety Profile
Assess dose limiting toxicity as defined in the protocol
Phase 1: Safety Profile
Assess maximum tolerated dose as defined in the protocol
Phase 1 and 2: Safety Profile
Frequency and severity of AEs and/or SAEs
Phase 2: Confirmed Objective Response Rate (ORR)
Proportion of patients who achieve a confirmed CR or PR

Secondary Outcome Measures

Phase 1: Pharmacokinetics
Plasma concentrations of ADC, total antibody and MMAE
Phase 1: Pharmacokinetics
Peak Plasma Concentration (Cmax)
Phase 1: Pharmacokinetics
Area under the plasma concentration versus time curve
Phase 1: Confirmed Objective Response Rate (ORR)
Proportion of patients who achieve a confirmed CR or PR
Phase 1: Immunogenicity
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Phase 1 and 2: Duration of response (DOR)
Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Phase 1 and 2: Progression-free survival (PFS)
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first
Phase 1 and 2: Best overall response (OR)
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Phase 1 and 2: Disease control rate (DCR)
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks
Phase 1 and 2: Time to response (TTR)
Time from the first dose of investigational product until the first documentation of OR
Phase 1 and 2: Overall survival (OS)
Time from the first dose of BA3021 treatment until death due to any cause
Phase 1 and 2: Tumor size
Percent change from baseline in tumor size

Full Information

First Posted
April 12, 2018
Last Updated
September 22, 2023
Sponsor
BioAtla, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03504488
Brief Title
CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)
Official Title
A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioAtla, Inc.

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
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors
Detailed Description
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors. This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, 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
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monotherapy - CAB-ROR2-ADC (BA3021) alone
Arm Type
Experimental
Arm Description
BA3021 alone Q2W dosing regimen
Arm Title
Combination Therapy
Arm Type
Experimental
Arm Description
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
Intervention Type
Biological
Intervention Name(s)
CAB-ROR2-ADC
Other Intervention Name(s)
BA3021
Intervention Description
Conditionally active biologic anti-ROR2 antibody drug conjugate
Intervention Type
Biological
Intervention Name(s)
PD-1 inhibitor
Intervention Description
PD-1 inhibitor
Primary Outcome Measure Information:
Title
Phase 1: Safety Profile
Description
Assess dose limiting toxicity as defined in the protocol
Time Frame
Up to 24 months
Title
Phase 1: Safety Profile
Description
Assess maximum tolerated dose as defined in the protocol
Time Frame
Up to 24 months
Title
Phase 1 and 2: Safety Profile
Description
Frequency and severity of AEs and/or SAEs
Time Frame
Up to 24 months
Title
Phase 2: Confirmed Objective Response Rate (ORR)
Description
Proportion of patients who achieve a confirmed CR or PR
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Phase 1: Pharmacokinetics
Description
Plasma concentrations of ADC, total antibody and MMAE
Time Frame
Up to 24 months
Title
Phase 1: Pharmacokinetics
Description
Peak Plasma Concentration (Cmax)
Time Frame
Up to 24 months
Title
Phase 1: Pharmacokinetics
Description
Area under the plasma concentration versus time curve
Time Frame
Up to 24 months
Title
Phase 1: Confirmed Objective Response Rate (ORR)
Description
Proportion of patients who achieve a confirmed CR or PR
Time Frame
Up to 24 months
Title
Phase 1: Immunogenicity
Description
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Time Frame
Up to 24 months
Title
Phase 1 and 2: Duration of response (DOR)
Description
Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Time Frame
Up to 24 months
Title
Phase 1 and 2: Progression-free survival (PFS)
Description
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first
Time Frame
Up to 24 months
Title
Phase 1 and 2: Best overall response (OR)
Description
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Time Frame
Up to 24 months
Title
Phase 1 and 2: Disease control rate (DCR)
Description
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks
Time Frame
Up to 24 months
Title
Phase 1 and 2: Time to response (TTR)
Description
Time from the first dose of investigational product until the first documentation of OR
Time Frame
Up to 24 months
Title
Phase 1 and 2: Overall survival (OS)
Description
Time from the first dose of BA3021 treatment until death due to any cause
Time Frame
Up to 24 months
Title
Phase 1 and 2: Tumor size
Description
Percent change from baseline in tumor size
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy. Patients must have measurable disease. For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS) Age ≥ 18 years. Adequate renal function Adequate liver function Adequate hematological function Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy of at least three months. Exclusion Criteria: Patients must not have clinically significant cardiac disease. Patients must not have known non-controlled CNS metastasis. Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas known or suspected allergy or intolerance to any agent given during this study. Patients must not have had major surgery within 4 weeks before first BA3021 administration. Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. Patients must not be women who are pregnant or breast feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BioAtla Medical Affairs
Phone
8585580708
Ext
3333
Email
medicalaffairs@bioatla.com
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Completed
Facility Name
City of Hope - Duarte
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edwin Smura
Email
esmura@coh.org
First Name & Middle Initial & Last Name & Degree
Mykola Onyshchenko, MD
Facility Name
University of California, San Diego (UCSD) - Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Alvendia
Email
kndu@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Lyudmila Bazhenova
Facility Name
California Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Gregorio
Email
cg@caresinst.com
First Name & Middle Initial & Last Name & Degree
Luiza Mnatsakanyan
Email
lm@caresinst.com
First Name & Middle Initial & Last Name & Degree
Ghassan Al-Jazayrly, MD
Facility Name
USC Norris
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Levano
Email
Jessica.Levano@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Jacob Thomas, MD
Facility Name
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
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
Samantha Noble
Email
snoble@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Misako Nagasaka
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markee Micu
Email
Markee.Micu@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Katy Tsai, MD
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Completed
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Medina, MD
Phone
303-266-3764
Email
theresa.medina@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Rebeca Elizondo
Phone
720-848-4288
Email
rebeca.elizondo@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
David Ross Camidge, MD
Facility Name
Sarah Cannon Research Institute at Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Falchook, MD
Phone
720-754-2610
Email
gerald.falchook@scresaerch.net
First Name & Middle Initial & Last Name & Degree
Susan Hall
Phone
720-754-2610
Email
Susan.Hall3@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Gerald Falchook, MD
Facility Name
Florida Cancer Specialists & Research Institute
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Gagne
Phone
904-269-6526
Email
sgagne@flcancer.com
First Name & Middle Initial & Last Name & Degree
Augusto Villegas, MD
Facility Name
Florida Cancer Specialists & Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna-May Bernard
Phone
239-274-9930
Email
Donna.Bernard@flcancer.com
First Name & Middle Initial & Last Name & Degree
Ivor Percent, MD
Facility Name
Memorial Cancer Institute (MCI)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Florida Cancer Specialist - North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyrae Layne
Email
Lyrae.Layne@flcancer.com
First Name & Middle Initial & Last Name & Degree
Vipul Patel, MD
Facility Name
Memorial Sloan-Kettering Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Andrews
Phone
813-745-3553
Email
Jacqueline.Andrews@moffitt.org
First Name & Middle Initial & Last Name & Degree
Mihaela Druta, MD
First Name & Middle Initial & Last Name & Degree
Andres Saltos, MD
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De'Dra Kelly
Phone
561-366-4100
Email
dkelly@flcancer.com
First Name & Middle Initial & Last Name & Degree
Eric Harris, MD
Facility Name
Augusta University - Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Jenkins
Email
kejenkins@augusta.edu
First Name & Middle Initial & Last Name & Degree
Girindra Raval
Facility Name
Baptist Health Systems
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Completed
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Howard
Email
sarah.kamer@uky.edu
First Name & Middle Initial & Last Name & Degree
Susanne Arnold, MD
Facility Name
Norton Cancer Institute, Brownsboro Hospital Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Adkisson
Email
Pamela.Adkisson@nortonhealthcare.org
First Name & Middle Initial & Last Name & Degree
Jaspreet Grewal, MD
Facility Name
Hematology/Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Alumbaugh
Phone
225-761-3951
Email
aimee.alumbaugh@aoncology.com
First Name & Middle Initial & Last Name & Degree
Michael Castine, MD
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
Comprehensive Cancer Care of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Completed
Facility Name
OptumCare Cancer Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianne Hergenroder
Phone
800-767-9355
Email
askroswell@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Edwin Yau, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaykov Viktor
Email
viktor.zaykov@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Elaine Shum, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
FirstHealth Outpatient Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Williams
Phone
910-715-1922
Email
jcwilliams@firsthealth.org
First Name & Middle Initial & Last Name & Degree
Charles Kuzma, MD
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Reed
Email
abby.reed@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
Monica Treta
Email
monica.treta@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
Alexander Starodub, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Completed
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deb Mayr
Phone
412-623-4029
Email
mayrdc@upmc.edu
First Name & Middle Initial & Last Name & Degree
Liza Villaruz, MD
Facility Name
Medical University of South Carolina- Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Leitner
Email
leitnera@musc.edu
First Name & Middle Initial & Last Name & Degree
Mariam Alexander, 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
Howard Burris, MD
Email
Howard.Burris@SarahCannon.com
First Name & Middle Initial & Last Name & Degree
Leigh Bumpous
Phone
615-748-0767
Email
Leigh.Bumpous@SarahCannon.com
First Name & Middle Initial & Last Name & Degree
Howard Burris, MD
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahogany Wadford
Email
mwadford@marycrowley.org
First Name & Middle Initial & Last Name & Degree
Reva Schneider, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoko Yamamura
Phone
713-792-9869
Email
yyamamur@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Siqing Fu, MD
Facility Name
University of Utah - Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Klonsky
Phone
801-581-5260
Email
Mia.Klonsky@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Ashley Lewary
Email
Ashley.Leary@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Joanne Jeter, MD
Facility Name
Norman Golchert
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norman PL Golchert
Email
norman.golchert@jsd.de
First Name & Middle Initial & Last Name & Degree
Christian Grohé
Facility Name
Jeanette Natschke
City
Berlin
ZIP/Postal Code
13359
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanette PL Natschke
Email
j.natschke@drk-kliniken-berlin.de
First Name & Middle Initial & Last Name & Degree
Bernd Schmidt
Facility Name
Thea Resch
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thea Resch
Email
t.resch@kem-med.com
First Name & Middle Initial & Last Name & Degree
Daniel Christoph
Facility Name
Asklepios Clinical Center Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Hundrieser
Email
n.hundrieser@asklepios.com
First Name & Middle Initial & Last Name & Degree
Claas Wesseler
Facility Name
HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit
City
Athens
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitrios Tzanos
Email
dtzanos86@gmail.com
First Name & Middle Initial & Last Name & Degree
Ioannis Mountzios
Facility Name
"Sotiria" Chest Diseases Hospital of Athens, 3rd Department of Internal Medicine of University of Athens, Oncology Unit
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roza Mariatou
Email
rmariatou@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Konstantinos Syrigos
Facility Name
Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department
City
Piraeus
ZIP/Postal Code
18547
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kanella-Maria Gkiati
Email
ongologiki1@metropolitan-hospital.gr
First Name & Middle Initial & Last Name & Degree
Eleni Linardou
Facility Name
Bioclinic Thessaloniki, Οncology Department
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiota Papadopoulou
Email
giota0806@gmail.com
First Name & Middle Initial & Last Name & Degree
Ioannis Boukovinas
Facility Name
European Interbalkan Medical Center, Οncology Department
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Papadopoulou
Email
elenhpap_1986@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sofia Baka
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herbert Loong, MD
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Yau, MD
Facility Name
Santa Maria delle Croci Hospital of Ravenna
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michela Spreafico
Email
michela.spreafico@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Manolo D'Arcangelo
Facility Name
"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
City
Genoa
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Zinoli
Email
linda.zinoli@hsanmartino.it
First Name & Middle Initial & Last Name & Degree
Carlo Genova
Facility Name
Polish Mother's Memorial Hospital-Research Institute
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Grubiak
Email
grubiak.marta@gmail.com
First Name & Middle Initial & Last Name & Degree
Ewa Kalinka
Facility Name
Beata Głogowska
City
Tomaszów Mazowiecki
State/Province
Lodzkie
ZIP/Postal Code
97-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beata Głogowska
Email
beata.glogowska@nu-med.pl
First Name & Middle Initial & Last Name & Degree
Ewa Chmielowska
Facility Name
Institute of Genetics and Immunology GENIM LCC in Lublin
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-609
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Reszka
Email
katarzyna.reszka1203@gmail.com2
First Name & Middle Initial & Last Name & Degree
Izabela Chmielewska
Facility Name
Malgorzata Kozlik
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
08-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Kozlik
Email
malgorzata.kozlik@pib-nio.pl
First Name & Middle Initial & Last Name & Degree
Dariusz Kowalski
Facility Name
MED-Polonia, Sp. z o.o. (LLC)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Ewert
Email
katarzyna.ewert@medpolonia.pl
First Name & Middle Initial & Last Name & Degree
Rodryg Ramlau
Facility Name
University Hospital Nuestra Senora de Valme
City
Sevilla
State/Province
Andalusia
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Diaz Álvarez
Email
valmeoncologia@yahoo.es
First Name & Middle Initial & Last Name & Degree
Jose Fuentes Pradera
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laia I Lavernia Rossell
Email
LLavernia@santpau.cat
First Name & Middle Initial & Last Name & Degree
Ivana Sullivan
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
089003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa I Lopez Parellada
Email
rlopezparellada@psmar.cat
First Name & Middle Initial & Last Name & Degree
Alvaro Taus
Facility Name
Anna Ramos Luna
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna I Ramos Luna
Email
aramosl@idibell.cat
First Name & Middle Initial & Last Name & Degree
Ernest Nadal
Facility Name
University Clinic of Navarra - Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Diaz Sanchez
Email
sdiazsanch@unav.es
First Name & Middle Initial & Last Name & Degree
Gonzalo Hinojal
Facility Name
University Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maripaz Soriano
Email
unidadfase1.imas12@h12o.es
First Name & Middle Initial & Last Name & Degree
Jon Zugazagoitia Fraile
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Ya Lin
Email
chanyai0725@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Chin-Chou Wang, MD
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shih-Han Chiu
Email
cshan08032020@gmail.com
First Name & Middle Initial & Last Name & Degree
Wu-Chou Su, MD
Facility Name
National Taiwan University Hospital
City
Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying-Chun Liu
Email
121630@ntuh.gov.tw
First Name & Middle Initial & Last Name & Degree
Jin-Yuan Shih, MD
Facility Name
LinKou Chang Gung Memorial Hospital
City
Taoyuan City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Ying Ou
Email
sherryou@hotmail.com
First Name & Middle Initial & Last Name & Degree
Wen-Cheng Chang, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

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