Trial Title:
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
NCT ID:
NCT05671510
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, open-label, active controlled, multi-center Phase 3 study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gotistobart
Description:
Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days
in assigned dose.
Arm group label:
Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W
Arm group label:
Arm 2: Gotistobart 3 mg/kg Q3W
Other name:
A humanized anti-CTLA4 IgG1 monoclonal antibody
Other name:
ONC-392
Other name:
BNT316
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days
in 75mg/m2 dose.
Arm group label:
Arm 3: Docetaxel 75 mg/m2, Q3W
Other name:
Docefrez
Other name:
Taxotere
Summary:
The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen
anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small
cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy.
The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel,
could prolong the life for NSCLC patients. Patients will be randomized to be treated with
either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in
approximately one year.
Detailed description:
This is a seamless 2-stage, randomized, open-label, active-controlled, Phase 3 study. The
study population consists of patients with NSCLC who progressed on PD-1/PD-L1 inhibitor.
Approximately 600 patients will be enrolled.
Two gotistobart dosing regimens will be tested in Stage I, and one will be selected for
Stage II.
Stage I, the dose-confirmation stage, will assess the efficacy and safety of two
gotistobart dosing regimens (3 mg/kg Q3W and 6 mg/kg Q3W with 2 loading doses of 10 mg/kg
Q3W) in comparison to docetaxel 75 mg/m2 Q3W.
Stage II will assess the safety and efficacy of gotistobart at the selected dosing
regimen versus docetaxel. Patients will be randomized 1:1 to receive either gotistobart
at the selected dosing regimen or docetaxel.
Criteria for eligibility:
Criteria:
Inclusion Criteria (Major criteria):
1. Adult (≥ 18 years), all genders, capable of signing informed consent.
2. Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC,
metastasis can be regional lymph nodes or distant organs.
3. Radiographic progression after treatment with the most recent line of treatment
being either 3a or 3b:
1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based
chemotherapy;
2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy,
followed by at least 12 weeks of standard doses of PD-1 or PD-L1
inhibitor-based immunotherapy.
Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with
PD-1/PD-L1 inhibitor are allowed.
4. At least one measurable tumor lesion according to RECIST 1.1.
5. ECOG score of 0 or 1.
6. Adequate organ functions. Serum LDH level ≤ 2xULN.
7. Life expectancy ≥ 3 months.
Exclusion Criteria (Major criteria):
1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except
endocrinopathy.
2. Last anti-PD-1/PD-L1 dosing within 28 days prior to first dose of study treatment.
3. Receiving systemic steroid therapy with >10 mg/day prednisone or equivalent within 7
days prior to the first dose of study treatment.
4. Having documented actionable mutations or genomic alterations in any of the
following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK;. Exception: KRAS
mutations are not excluded.
5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or
radiosurgery to brain metastasis within 14 days of the first dose of study drug.
6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or
inflammatory bowel disease.
7. Active interstitial lung disease (ILD) or non-infectious pneumonitis.
8. Active infections with IV antibiotics within 14 days prior to first dose of study
treatment.
9. Impaired heart function.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
XCancer/Dothan Hematology & Oncology - 1114
Address:
City:
Dothan
Zip:
36303
Country:
United States
Facility:
Name:
Genesis Cancer and Blood Institute - 1123
Address:
City:
Russellville
Zip:
72801
Country:
United States
Facility:
Name:
The Oncology Institute (TOI) Clinical Research - 1109
Address:
City:
Cerritos
Zip:
90703
Country:
United States
Facility:
Name:
Emad Ibrahim MD Inc. - 1147
Address:
City:
Redlands
Zip:
92373
Country:
United States
Facility:
Name:
UC Davis Comprehensive Cancer Center - 1103
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Facility:
Name:
Bass Medical Group - 1155
Address:
City:
Walnut Creek
Zip:
94598
Country:
United States
Facility:
Name:
Nuvance Health - 1118
Address:
City:
Norwalk
Zip:
06850
Country:
United States
Facility:
Name:
D&H Cancer Research Center LLC - 1153
Address:
City:
Margate
Zip:
33063
Country:
United States
Facility:
Name:
Ocala Oncology Center PL - 1102
Address:
City:
Ocala
Zip:
34474
Country:
United States
Facility:
Name:
AdventHealth Cancer Institute - 1105
Address:
City:
Orlando
Zip:
32804
Country:
United States
Facility:
Name:
Orlando Health - 1130
Address:
City:
Orlando
Zip:
32806
Country:
United States
Facility:
Name:
Florida Cancer Specialists -South - 1126
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Facility:
Name:
Florida Cancer Specialists -North - 1125
Address:
City:
The Villages
Zip:
32159
Country:
United States
Facility:
Name:
Florida Cancer Specialists -East - 1124
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Facility:
Name:
Orchard Healthcare Research, Inc. - 1116
Address:
City:
Skokie
Zip:
60077
Country:
United States
Facility:
Name:
Springfield Clinic - The Cancer Center - 1110
Address:
City:
Springfield
Zip:
62702
Country:
United States
Facility:
Name:
Fort Wayne Medical Oncology - 1133
Address:
City:
Fort Wayne
Zip:
46805
Country:
United States
Facility:
Name:
Deaconess Chancellor Center for Oncology - 1131
Address:
City:
Newburgh
Zip:
47630
Country:
United States
Facility:
Name:
Alliance for Multispecialty Research, LLC - 1144
Address:
City:
Merriam
Zip:
66204
Country:
United States
Facility:
Name:
Cotton O'Neil Clinical Research Center - 1151
Address:
City:
Topeka
Zip:
66606
Country:
United States
Facility:
Name:
University of Kentucky - Markey Cancer Center - 1112
Address:
City:
Lexington
Zip:
40536
Country:
United States
Facility:
Name:
Norton Cancer Institute - 1108
Address:
City:
Louisville
Zip:
40202
Country:
United States
Facility:
Name:
Hematology Oncology Clinics - Baton Rouge - 1142
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Facility:
Name:
HealthPartners Institute, Cancer Research Center - 1143
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Facility:
Name:
Jefferson City Medical Group - 1145
Address:
City:
Jefferson City
Zip:
65109
Country:
United States
Facility:
Name:
NHO-Revive Research Institute, LLC - 1152
Address:
City:
Lincoln
Zip:
68506
Country:
United States
Facility:
Name:
Astera Cancer Care - 1128
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Facility:
Name:
Messino Cancer Centers - 1121
Address:
City:
Asheville
Zip:
28806
Country:
United States
Facility:
Name:
University of Cincinnati Cancer Center - 1107
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Facility:
Name:
The Ohio State University James Cancer Center - 1104
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Miami Valley Hospital - 1115
Address:
City:
Dayton
Zip:
45409
Country:
United States
Facility:
Name:
Tri County Hematology & Oncology Associates, Inc - 1156
Address:
City:
Massillon
Zip:
44646
Country:
United States
Facility:
Name:
Oncology Associates of Oregon - 1138
Address:
City:
Eugene
Zip:
97401
Country:
United States
Facility:
Name:
Pennsylvania Cancer Specialists Research Institute - 1101
Address:
City:
Gettysburg
Zip:
17325
Country:
United States
Facility:
Name:
Donald Guthrie Foundation - 1135
Address:
City:
Sayre
Zip:
18840
Country:
United States
Facility:
Name:
Cancer Care Associates of York, Inc. - 1113
Address:
City:
York
Zip:
17403
Country:
United States
Facility:
Name:
University of Tennessee Medical Center - 1146
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute - Tennessee Oncology at Nashville - 1119
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Texas Oncology -Dallas - 1127
Address:
City:
Dallas
Zip:
75230
Country:
United States
Facility:
Name:
Texas Oncology - Baylor Charles A. Sammons Cancer Center (USOR) - 1140
Address:
City:
Dallas
Zip:
75246
Country:
United States
Facility:
Name:
Texas Oncology - Denison - 1139
Address:
City:
Denison
Zip:
75020
Country:
United States
Facility:
Name:
Texas Oncology - Fort Worth Cancer Center - 1141
Address:
City:
Fort Worth
Zip:
76105
Country:
United States
Facility:
Name:
Oncology Consultants, P.A. - 1120
Address:
City:
Houston
Zip:
77024
Country:
United States
Facility:
Name:
Texas Oncology - McAllen - 1132
Address:
City:
McAllen
Zip:
78503
Country:
United States
Facility:
Name:
Texas Oncology - Plano West - 1137
Address:
City:
Plano
Zip:
75093
Country:
United States
Facility:
Name:
Texas Oncology -San Antonio - 1122
Address:
City:
San Antonio
Zip:
78240
Country:
United States
Facility:
Name:
Texas Oncology - Northeast Texas - Tyler - 1134
Address:
City:
Tyler
Zip:
75702
Country:
United States
Facility:
Name:
NEXT Oncology - Virginia - 1129
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
Virginia Cancer Institute - 1149
Address:
City:
Henrico
Zip:
23226
Country:
United States
Facility:
Name:
Virginia Oncology Associates - 1136
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Facility:
Name:
MultiCare Institute for Research and Innovation - Tacoma - 1148
Address:
City:
Spokane
Zip:
99218
Country:
United States
Facility:
Name:
Bankstown Hospital - 3305
Address:
City:
Bankstown
Zip:
2200
Country:
Australia
Facility:
Name:
Newcastle Private Hospital - 3302
Address:
City:
New Lambton Heights
Country:
Australia
Facility:
Name:
Mater - 3301
Address:
City:
Newstead
Zip:
4006
Country:
Australia
Facility:
Name:
Cancer Research SA - 3303
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Facility:
Name:
AZ Maria Middelares - 2104
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Facility:
Name:
Jessa Ziekenhuis (Jessa Hospital) - Campus Salvator - 2102
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Facility:
Name:
C. H. R. de la Citadelle - 2103
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Facility:
Name:
Vitaz - Sint-niklaas Moerland - 2101
Address:
City:
Sint-Niklaas
Zip:
9100
Country:
Belgium
Facility:
Name:
BC Cancer Centre - Kelowna - 1203
Address:
City:
Kelowna
Country:
Canada
Facility:
Name:
Saskatchewan Cancer Agency - Regina - 1201
Address:
City:
Regina
Zip:
S4T 7T1
Country:
Canada
Facility:
Name:
Saskatchewan Cancer Agency - Saskatoon Cancer Centre - 1202
Address:
City:
Saskatoon
Zip:
S7N 4H4
Country:
Canada
Facility:
Name:
Santa Cabrini Hospital - 1204
Address:
City:
Québec
Zip:
H1T1P7
Country:
Canada
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University - 3221
Address:
City:
Hefei
Zip:
230022
Country:
China
Facility:
Name:
Anhui Medical University - The Second Hospital - 3222
Address:
City:
Hefei
Zip:
231200
Country:
China
Facility:
Name:
Beijing Cancer Hospital - 3205
Address:
City:
Beijing
Country:
China
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences - 3211
Address:
City:
Beijing
Country:
China
Facility:
Name:
Fujian Medical University Union Hospital - 3225
Address:
City:
Fuzhou
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xiamen University - 3210
Address:
City:
Xiamen
Country:
China
Facility:
Name:
Dongguan People's Hospital - 3206
Address:
City:
Dongguan
Country:
China
Facility:
Name:
Guangdong Provincial People's Hospital - 3201
Address:
City:
Guangzhou
Zip:
510105
Country:
China
Facility:
Name:
Zhujiang Hospital of Southern Medical University - 3203
Address:
City:
Guangzhou
Zip:
510280
Country:
China
Facility:
Name:
The First Affiliated Hospital of Guangdong Pharmaceutical University - 3215
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
The People's Hospital of Guangxi Zhuang Autonomous Region - 3228
Address:
City:
Nanning
Zip:
530021
Country:
China
Facility:
Name:
Hainan General Hospital - 3202
Address:
City:
Haikou
Country:
China
Facility:
Name:
Affiliated Hospital of Hebei University - 3214
Address:
City:
Zhengzhou
Zip:
71000
Country:
China
Facility:
Name:
The Affiliated Tumor Hospital of Harbin Medical University - 3232
Address:
City:
Harbin
Zip:
150040
Country:
China
Facility:
Name:
Henan Cancer Hospital - 3226
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
The First Affliated Hospital of Zhengzhou University - 3207
Address:
City:
Zhengzhou
Country:
China
Facility:
Name:
Renmin Hospital of Wuhan University - 3216
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Union Hospital Tongji Medical College - 3212
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Xiangya Hospital, Central South University - 3223
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
Hunan Cancer Hospital - 3209
Address:
City:
Changsha
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Soochow University - 3217
Address:
City:
Suzhou
Country:
China
Facility:
Name:
Xuzhou Medical University - The Affiliated Hospital - 3234
Address:
City:
Xuzhou
Zip:
221002
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Nanchang University - 3224
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
Jinan Central Hospital - 3230
Address:
City:
Jinan
Zip:
250013
Country:
China
Facility:
Name:
Shanxi Bethune Hospital - 3233
Address:
City:
Taiyuan
Zip:
30032
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University - 3218
Address:
City:
Xi'an
Country:
China
Facility:
Name:
Chengdu Seventh People's Hospital - 3229
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Sichuan Cancer Hospital - 3227
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Chongqing University Cancer Hospital - 3213
Address:
City:
Chongqing
Country:
China
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital - 3208
Address:
City:
Tianjin
Country:
China
Facility:
Name:
Yunnan Cancer Hospital - 3231
Address:
City:
Kunming
Zip:
650118
Country:
China
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - 3219
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University School of Medicine - 3220
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital - 3204
Address:
City:
Hangzhou
Country:
China
Facility:
Name:
China-Japan Friendship Hospital - 3236
Address:
City:
Beijing
Zip:
100029
Country:
China
Facility:
Name:
West China Hospital, Sichuan University - 3238
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Nanjing Medical University (NMU) - Nanjing First Hospital - 3239
Address:
City:
Jiangse
Zip:
21006
Country:
China
Facility:
Name:
Weifang Second People's Hospital - 3235
Address:
City:
Shandong
Zip:
261041
Country:
China
Facility:
Name:
Tongji University - Shanghai Oriental Hospital (Shanghai East Hospital) - 3240
Address:
City:
Shanghai
Zip:
200120
Country:
China
Facility:
Name:
Hubei Cancer Hospital - 3237
Address:
City:
Wuhan
Zip:
430079
Country:
China
Facility:
Name:
Hôpital Ambroise Paré - 2501
Address:
City:
Billancourt
Zip:
92100
Country:
France
Facility:
Name:
Centre Hospitalier Intercommunal de Créteil - 2502
Address:
City:
Créteil
Zip:
94000
Country:
France
Facility:
Name:
CHU Limoges - Hospital du Cluzeau - 2503
Address:
City:
Limoges
Country:
France
Facility:
Name:
Städt. Klinikum München GmbH - 2204
Address:
City:
Bogenhausen
Zip:
81925
Country:
Germany
Facility:
Name:
Kliniken Essen-Mitte - 2206
Address:
City:
Essen
Zip:
45136
Country:
Germany
Facility:
Name:
Klinikum Esslingen GmbH - 2201
Address:
City:
Esslingen am Neckar
Zip:
73730
Country:
Germany
Facility:
Name:
Lungenfachklinik Immenhausen - 2202
Address:
City:
Immenhausen
Zip:
34376
Country:
Germany
Facility:
Name:
Klinikverbund Allgaü - Klinikum Kempten - 2205
Address:
City:
Immenstädt
Zip:
87509
Country:
Germany
Facility:
Name:
Asklepios Fachkliniken Muenchen-Gauting - 2203
Address:
City:
Muenchen-Gauting
Zip:
82131
Country:
Germany
Facility:
Name:
Clinica Oncologica Ospedali Riuniti Ancona - 2311
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Facility:
Name:
IRCCS Istituto Tumori Giovanni Paolo II - 2306
Address:
City:
Bari
Zip:
70124
Country:
Italy
Facility:
Name:
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - 2310
Address:
City:
Bergamo
Zip:
24126
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Papardo - 2301
Address:
City:
Messina
Zip:
98158
Country:
Italy
Facility:
Name:
Ospedale San Raffaele - 2307
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
Fondazione IRCCS Instituto Tumori Di Milano - 2305
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
Ospedale San Gerardo di Monza - 2302
Address:
City:
Monza
Zip:
20900
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria "Federico II" - 2304
Address:
City:
Naples
Zip:
80131
Country:
Italy
Facility:
Name:
AOU Policlinico Giaccone, Università di Palermo - 2309
Address:
City:
Palermo
Zip:
90129
Country:
Italy
Facility:
Name:
Universita degli Studi di Perugia - Ospedale Santa Maria della Misericordia - 2308
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Facility:
Name:
Universita Campus Bio-medico Di Roma (UCBM) - Policlinico Universitario - 2303
Address:
City:
Roma
Zip:
00128
Country:
Italy
Facility:
Name:
Chungbuk National University Hospital - 3101
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Facility:
Name:
Keimyung University Dongsan Hospital - 3102
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Facility:
Name:
National Cancer Center - 3107
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital, Yonsei University Health System - 3104
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Centre - 3103
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Korea University Guro Hospital - 3106
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Facility:
Name:
The Catholic University of Korea, St Vincent's Hospital - 3105
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Facility:
Name:
Antoni van Leeuwenhoek - 2703
Address:
City:
Amsterdam
Zip:
1066 CV
Country:
Netherlands
Facility:
Name:
Rijnstate Ziekenhuis - 2701
Address:
City:
Arnhem
Zip:
6815
Country:
Netherlands
Facility:
Name:
Jeroen Bosch Ziekenhuis - 2702
Address:
City:
Herzogenbusch
Zip:
5223
Country:
Netherlands
Facility:
Name:
ETZ Elisabeth - 2704
Address:
City:
Tilburg
Zip:
5022 GC
Country:
Netherlands
Facility:
Name:
Hospital General Universitario de Elche - 2401
Address:
City:
Elche
Zip:
03203
Country:
Spain
Facility:
Name:
Hospital Universitario Lucus Augusti - 2405
Address:
City:
Lugo
Zip:
27003
Country:
Spain
Facility:
Name:
Hospital General Universitario Gregorio Marañon - 2404
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Facility:
Name:
Hospital Regional Universitario de Malaga - 2403
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Facility:
Name:
Hospital General Universitario de Valencia - 2406
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Facility:
Name:
Fundacion Instituto Valenciano De Oncologia (IVO) - 2402
Address:
City:
Valencia
Zip:
56009
Country:
Spain
Facility:
Name:
Adana Sehir Hastanesi - 2602
Address:
City:
Adana
Country:
Turkey
Facility:
Name:
Baskent University Adana - 2601
Address:
City:
Adana
Country:
Turkey
Facility:
Name:
Hacettepe Universitesi - 2609
Address:
City:
Ankara
Zip:
06230
Country:
Turkey
Facility:
Name:
Ankara Bilkent Sehir Hastanesi - 2610
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Facility:
Name:
Akdeniz University Medical Hospital - 2606
Address:
City:
Antalya
Country:
Turkey
Facility:
Name:
Ege Universitesi Hastanesi - 2612
Address:
City:
Bornova
Zip:
35100
Country:
Turkey
Facility:
Name:
Trakya University Faculty of Medicine Edirne - 2608
Address:
City:
Edirne
Country:
Turkey
Facility:
Name:
Istanbul Üniversitesi Onkoloji Enstitüsü - 2613
Address:
City:
Fatih
Zip:
34093
Country:
Turkey
Facility:
Name:
Koc Universitesi - 2611
Address:
City:
Istanbul
Zip:
34010
Country:
Turkey
Facility:
Name:
Göztepe Prof Dr. Suleyman Yalcin City Hospital - 2605
Address:
City:
Istanbul
Country:
Turkey
Facility:
Name:
Istanbul Bakirkoy Sadi Konuk - 2604
Address:
City:
Istanbul
Country:
Turkey
Facility:
Name:
Medipol University Medical Faculty Hospital - 2603
Address:
City:
Istanbul
Country:
Turkey
Facility:
Name:
Izmir Ekonomi Universitesi Medical Point Hastanesi - 2607
Address:
City:
İzmir
Country:
Turkey
Facility:
Name:
University Hospital Birmingham (UHB) / Queen Elizabeth Hospital Birmingham - 2801
Address:
City:
Birmingham
Zip:
B15 2TG
Country:
United Kingdom
Facility:
Name:
Cambridge University Hospitals - 2804
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Facility:
Name:
Royal Devon University Healthcare NHS - 2808
Address:
City:
Exeter
Zip:
EX25DW
Country:
United Kingdom
Facility:
Name:
University Hospital Leicester - 2806
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Facility:
Name:
The Christie NHS Foundation Trust - 2803
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Facility:
Name:
Barts Health NHS Trust (St. Bartholomew's Hospital) - 2802
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Facility:
Name:
South Tees Hospitals - 2807
Address:
City:
Middlesbrough
Zip:
TS4 3BW
Country:
United Kingdom
Facility:
Name:
University Hospital Southampton - 2810
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Facility:
Name:
Torbay Hospital - Horizon Centre - 2805
Address:
City:
Torquay
Zip:
TQ2 7AA
Country:
United Kingdom
Facility:
Name:
Edinburgh Cancer Centre - 2809
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Start date:
June 28, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
OncoC4, Inc.
Agency class:
Industry
Collaborator:
Agency:
BioNTech SE
Agency class:
Industry
Source:
OncoC4, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05671510
