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Study of INBRX-109 in Conventional Chondrosarcoma (ChonDRAgon)

Primary Purpose

Conventional Chondrosarcoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INBRX-109
Placebo
Sponsored by
Inhibrx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conventional Chondrosarcoma focused on measuring DR5, INBRX-109, Apoptosis, Programmed cell death

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
  2. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
  3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
  4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  6. Estimated life expectancy of at least 12 weeks.
  7. Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion Criteria:

  1. Any prior exposure to DR5 agonists.
  2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
  3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
  4. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
  5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion criteria is confirmed.
  6. Other exclusion criteria per protocol.

Sites / Locations

  • Mayo Clinic Cancer CenterRecruiting
  • University of California, San Francisco (UCSF)Recruiting
  • Sarcoma Oncology CenterRecruiting
  • University of ColoradoRecruiting
  • Mayo Clinic - JacksonvilleRecruiting
  • Moffitt Cancer CenterRecruiting
  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center
  • Rush Cancer CenterRecruiting
  • University of Iowa
  • Johns HopkinsRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Massachusetts General HospitalRecruiting
  • University of MichiganRecruiting
  • Washington University School of Medicine - St. LouisRecruiting
  • Nebraska Methodist HospitalRecruiting
  • Norris Cotton Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Columbia UniversityRecruiting
  • Duke UniversityRecruiting
  • Cleveland ClinicRecruiting
  • Oklahoma State University (OSU) - Stephenson Cancer CenterRecruiting
  • Oregon Health & Science University (OHSU) Knight Cancer InstituteRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • University of Texas SouthwesternRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Virginia Cancer SpecialistsRecruiting
  • Washington University - SeattleRecruiting
  • Royal Adelaide Hospital
  • Chris O'Brien Lifehouse
  • Princess Alexandra Hospital
  • Institut Bergonie
  • Centre Leon BerardRecruiting
  • AP-HM - Hôpital de la TimoneRecruiting
  • Gustave RoussyRecruiting
  • Helios Klinikum Berlin-BuchRecruiting
  • Universitätsmedizin MannheimRecruiting
  • Saint Vincent's University Hospital part of Irish Sarcoma GroupRecruiting
  • IRCCS Istituto Ortopedico Rizzoli di BolognaRecruiting
  • La Fondazione e l'Istituto di CandioloRecruiting
  • Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
  • Nuovo Ospedale di PratoRecruiting
  • Policlinico Universitario Campus BiomedicoRecruiting
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Groningen UMCRecruiting
  • Leiden University Medical CenterRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital de la Santa Creu i Sant Pau BarcelonaRecruiting
  • Hospital Clinico San CarlosRecruiting
  • Hospital Fundación Jiménez DíazRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Ankara City Hospital
  • Uludag University Medical Faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Erciyes University Faculty of Medicine
  • University College London Hospital (UCL)Recruiting
  • Royal Marsden NHS Foundation TrustRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • Churchill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

INBRX-109

Placebo

Arm Description

IV every three weeks

IV every three weeks

Outcomes

Primary Outcome Measures

Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo
Progression-free survival per RECISTv1.1 will be determined.

Secondary Outcome Measures

Overall survival of patients comparing INBRX-109 and placebo
Overall Survival in the ITT population
Overall response rate (in percent), duration of response (in time) and disease control rate (in percent)
Tumor response will be determined by RECISTv1.1.
PFS per RECISTv1.1 by Investigator assessment
PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo
Quality of life will be determined.
DCR per RECISTv1.1 by real-time IRR
measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
DOR per RECISTv1.1 by real-time IRR
evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
To evaluate the safety and tolerability of INBRX-109
Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Characterize the pharmacokinetics of INBRX-109.
AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non- Sponsor: Inhibrx, Inc. Version 5.0 (Amendment 4) Protocol Number: Ph2 INBRX-109 SA CS 28-Feb-2023 Page 41 of 113 CONFIDENTIAL Objective Endpoint compartmental method as the data allow. Other PK parameters (λz, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough)
Immunogenicity of INBRX-109
Frequency of anti-drug antibodies against INBRX-109 will be determined.

Full Information

First Posted
June 14, 2021
Last Updated
September 26, 2023
Sponsor
Inhibrx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04950075
Brief Title
Study of INBRX-109 in Conventional Chondrosarcoma
Acronym
ChonDRAgon
Official Title
A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inhibrx, 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
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
Detailed Description
This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conventional Chondrosarcoma
Keywords
DR5, INBRX-109, Apoptosis, Programmed cell death

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
INBRX-109 and placebo arms are in parallel. Patients on placebo are allowed to cross-over to open-label INBRX-109 at time of disease progression.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INBRX-109
Arm Type
Experimental
Arm Description
IV every three weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IV every three weeks
Intervention Type
Drug
Intervention Name(s)
INBRX-109
Intervention Description
Tetravalent DR5 Agonist Antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo
Description
Progression-free survival per RECISTv1.1 will be determined.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival of patients comparing INBRX-109 and placebo
Description
Overall Survival in the ITT population
Time Frame
3 years
Title
Overall response rate (in percent), duration of response (in time) and disease control rate (in percent)
Description
Tumor response will be determined by RECISTv1.1.
Time Frame
3 years
Title
PFS per RECISTv1.1 by Investigator assessment
Description
PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
Time Frame
3 years
Title
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo
Description
Quality of life will be determined.
Time Frame
3 years
Title
DCR per RECISTv1.1 by real-time IRR
Description
measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
Time Frame
3 years
Title
DOR per RECISTv1.1 by real-time IRR
Description
evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
Time Frame
3 years
Title
To evaluate the safety and tolerability of INBRX-109
Description
Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Time Frame
3 years
Title
Characterize the pharmacokinetics of INBRX-109.
Description
AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non- Sponsor: Inhibrx, Inc. Version 5.0 (Amendment 4) Protocol Number: Ph2 INBRX-109 SA CS 28-Feb-2023 Page 41 of 113 CONFIDENTIAL Objective Endpoint compartmental method as the data allow. Other PK parameters (λz, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough)
Time Frame
3 years
Title
Immunogenicity of INBRX-109
Description
Frequency of anti-drug antibodies against INBRX-109 will be determined.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Evaluate Quality of Life
Description
QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S
Time Frame
3 years
Title
Potential predictive response biomarkers
Description
Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109
Time Frame
3 years
Title
PFS per RECISTv1.1 by Investigator assessment
Description
evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109
Time Frame
3 years
Title
ORR per RECISTv1.1 by Investigator assessment
Description
evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109
Time Frame
3 years

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Conventional chondrosarcoma, unresectable (=inoperable) or metastatic. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. Estimated life expectancy of at least 12 weeks. Availability of archival tissue or fresh cancer biopsy are mandatory. Exclusion Criteria: Any prior exposure to DR5 agonists. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders. Other exclusion criteria per protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Darling
Phone
858-500-7833
Email
clinicaltrials@inhibrx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Bayer
Email
clinicaltrials@inhibrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasily Andrianov, MD
Organizational Affiliation
Inhibrx, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - All Mayo Locations
Phone
855-776-0015
Ext
(toll free)
First Name & Middle Initial & Last Name & Degree
Mahesh Seetharam, MD
Facility Name
University of California, San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bianca Bacaltos, CRS
Phone
415-866-7925
Email
bianca.bacaltos@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Victoria Wang, MD
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Chua-Alcala
Phone
310-552-9999
Email
vchua@sarcomaoncology.com
First Name & Middle Initial & Last Name & Degree
Sant P Chawla, MD
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Frisbie
Phone
720-848-0734
Email
Natalie.Frisbie@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Breelyn Wilky, MD
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - All Mayo Locations
Phone
855-776-0015
Ext
(toll free)
First Name & Middle Initial & Last Name & Degree
Steven Attia, MD
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
Martha Fuentes
Phone
813-745-0265
Email
martha.fuentes@moffitt.org
First Name & Middle Initial & Last Name & Degree
Andrew Brohl, MD
Facility Name
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Knott
Phone
312-695-1352
Email
hannah.knott@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Seth Pollack, MD
Facility Name
Rush Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey Woods
Phone
312-563-2008
Email
Corey_J_Woods@rush.edu
First Name & Middle Initial & Last Name & Degree
Marta Batus, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teena Davis-Vandaele
Phone
319-467-5834
Email
teena-vandaele@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Katie Keeler
Email
katie-cannon@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Mohammed Milhem, MD
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
Phone
410-955-3008
Email
Cmeyer13@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Alex Thompson
Phone
410-955-3008
Email
athomp43@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Christian Meyer, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarcoma Research
Phone
617-632-5204
First Name & Middle Initial & Last Name & Degree
Andrew Wagner, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Finn
Phone
617-724-4257
Email
kfinn5@partners.org
First Name & Middle Initial & Last Name & Degree
Gregory Cote, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina Verdiyan
Phone
734-647-8902
Email
limendel@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Rashmi Chugh, MD
Facility Name
Washington University School of Medicine - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolene Steibel
Phone
314-273-5895
Email
jolene@wustl.edu
First Name & Middle Initial & Last Name & Degree
Brian Van Tine, MD
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Bartz
Phone
402-354-7939
Email
Kathryn.Bartz@nmhs.org
First Name & Middle Initial & Last Name & Degree
Kirsten Leu, MD
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob DuBien
Phone
603-650-4595
Email
jacob.r.dubien@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Garrett Wasp, MD
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Phelan
Phone
646-888-6952
First Name & Middle Initial & Last Name & Degree
Ciara Kelly, MD
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurse Navigator
Phone
212-342-5162
Email
cancerclinicaltrials@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Shaheer Khan, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soren Evers
Phone
919-681-1888
Email
soren.evers@duke.edu
First Name & Middle Initial & Last Name & Degree
Richard Riedel, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Keaney
Phone
216-444-3409
Email
keaneyh@ccf.org
First Name & Middle Initial & Last Name & Degree
Dale Shepard, MD
Facility Name
Oklahoma State University (OSU) - Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Yarbrough, RN
Phone
405-271-8001
Ext
48340
Email
melissa-yarbrough@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Minh Phan, MD
Facility Name
Oregon Health & Science University (OHSU) Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray Jackson
Phone
503-494-5749
Email
jacksray@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Lara Davis, MD
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Hubert
Phone
215-955-9954
Email
christine.hubert@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Atrayee Basu-Mallick, MD
Facility Name
University of Pittsburgh Medical 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
Amy Rose
Phone
412-647-8587
Email
kennaj@upmc.edu
First Name & Middle Initial & Last Name & Degree
Melissa Burgess, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Taylor
Phone
615-875-0060
Email
kathy.l.taylor@vumc.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Davis, MD
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Thomas, BSN, RN
Phone
214-648-7358
Email
tiffany.thomas@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Jade Homsi, 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
Jaqueline Rios
Phone
713-792-7289
Email
JRios2@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Anthony Conley, MD
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Friedman
Phone
703-636-1473
Email
Carrie.friedman@usoncology.com
First Name & Middle Initial & Last Name & Degree
Alexander Spira, MD
Facility Name
Washington University - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roxanne Moore
Phone
206-606-6425
Email
romoore@seattlecca.org
First Name & Middle Initial & Last Name & Degree
Lee Cranmer, MD
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimit Singhal, MD
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Grimison, MD
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Andelkovic, MD
Facility Name
Institut Bergonie
City
Bordeaux
State/Province
Cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Retailleau
Phone
(+33) 05-56-33-32-30
Email
j.retailleau@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Maud Toulmonde, MD
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Timmins
Phone
+33 478 786 035
Email
julien.timmins@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Jean-Yves Blay, MD
Facility Name
AP-HM - Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annick Pelletier
Phone
+33 491 38 46 43
Email
annick.pelletier@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Florence Duffaud, MD
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmine Bouredjoul
Email
Yasmine.BOUREDJOUL@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Axel Le Cesne, MD
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Hammermeister
Phone
+49 30 9401-14888
Email
Miriam.Hammermeister@helios-gesundheit.de
First Name & Middle Initial & Last Name & Degree
Peter Reichardt, MD
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Kollak
Phone
+49 (0) 621 383-5168
Email
Adalbert.Kollak@umm.de
First Name & Middle Initial & Last Name & Degree
Peter Hohenberger, MD
Facility Name
Saint Vincent's University Hospital part of Irish Sarcoma Group
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Mahon
Phone
+353 1221 4469
Email
amy.mahon@ccrt.ie
First Name & Middle Initial & Last Name & Degree
Mark Doherty, MD
Facility Name
IRCCS Istituto Ortopedico Rizzoli di Bologna
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michela Pierini
Phone
+39 051.63.66.668
Email
michela.pierini@ior.it
First Name & Middle Initial & Last Name & Degree
Emanuela Palmerini, MD
Facility Name
La Fondazione e l'Istituto di Candiolo
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Morabito
Phone
+39 011 993 3283
Email
simone.morabito@ircc.it
First Name & Middle Initial & Last Name & Degree
Sandra Aliberti, MD
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matilde Ingrosso
Phone
+39 0223903287
Email
Matilde.Ingrosso@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti
Facility Name
Nuovo Ospedale di Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Delmonte
Phone
0574 802531
Email
francesca.delmonte@uslcentro.toscana.it
First Name & Middle Initial & Last Name & Degree
Giacomo Baldi, MD
Facility Name
Policlinico Universitario Campus Biomedico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Grassani
Phone
+39 06225418855
Email
t.grassani@policlinicocampus.it
First Name & Middle Initial & Last Name & Degree
Bruno Vincenzi, MD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miso Kim, MD
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Hee Ahn, MD
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Yong Hong, MD
Facility Name
Groningen UMC
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fokje de Zwart
Phone
050-3616161
Email
f.r.de.zwart@umcg.nl
First Name & Middle Initial & Last Name & Degree
Jacco de Haan, MD
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margret den Hollander
Phone
+31 715263756
Email
m.a.g.den_hollander@lumc.nl
First Name & Middle Initial & Last Name & Degree
Andre (Hans) Gelderbloom, 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
Carlos Fernandez
Phone
+34 932746000
Email
cfernandez@vhio.net
First Name & Middle Initial & Last Name & Degree
Claudia Valverde, MD
Facility Name
Hospital de la Santa Creu i Sant Pau Barcelona
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Gonzalez Gomez
Phone
(34) 935565827
Email
lgonzalezgo@santpau.cat
First Name & Middle Initial & Last Name & Degree
Ana Sebio Garcia, MD, PhD
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Olivera Frade
Phone
34 91 330 30 00 Ext 7498
Email
helenaolivera.hcsc@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonio Casado, MD
Facility Name
Hospital Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Flores
Phone
34 607296691
Email
aflores@atbsarc.org
First Name & Middle Initial & Last Name & Degree
Javier Martin-Broto, MD, PhD
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayte Giralt
Phone
+ 34 961 24 41 88
Email
giralt_mai@gva.es
First Name & Middle Initial & Last Name & Degree
Roberto Diaz Beveridge, MD
Facility Name
Ankara City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Ali Nahit Sendur, MD
Facility Name
Uludag University Medical Faculty
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Turkkan Evrensel, MD
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Ozguroglu, MD
Facility Name
Erciyes University Faculty of Medicine
City
Melikgazi
ZIP/Postal Code
38030
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oktay Bozkurt, MD
Facility Name
University College London Hospital (UCL)
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Searle
Phone
+442034472929
Email
tara.searle@nhs.net
First Name & Middle Initial & Last Name & Degree
Sandra Strauss, MD
Facility Name
Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kowsar Ahmed
Email
Kowsar.Ahmed@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Robin Jones, Prof.
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Burek
Phone
+44 (0)161 918 2357
Email
monika.burek@nhs.net
First Name & Middle Initial & Last Name & Degree
Alexander Lee, MD
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
harriet Bradford White
Email
Harriet.BranfordWhite@ouh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Sarah Pratap, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of INBRX-109 in Conventional Chondrosarcoma

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