Trial Title:
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
NCT ID:
NCT06467357
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Gemcitabine
Trastuzumab
Durvalumab
Trastuzumab deruxtecan
Conditions: Keywords:
Biliary Tract Cancer
HER2
HER2 expressing BTC
Trastuzumab deruxtecan
T-DXd
Rilvegostomig
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
This is an open-label, Sponsor-blinded study. To maintain the integrity of the study,
Sponsor personnel directly involved in study conduct will not undertake or have access to
efficacy data aggregated by treatment group prior to final data readout for the primary
endpoint.
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Standard of care chemotherapy by intravenous infusion
Arm group label:
Standard of Care
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Standard of care chemotherapy by intravenous infusion
Arm group label:
Standard of Care
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Standard of care immunotherapy by intravenous infusion
Arm group label:
Standard of Care
Intervention type:
Drug
Intervention name:
Trastuzumab deruxtecan
Description:
Experimental therapy by intravenous infusion
Arm group label:
Trastuzumab deruxtecan
Arm group label:
Trastuzumab deruxtecan + rilvegostomig
Other name:
DS-8201a; T-DXd
Intervention type:
Drug
Intervention name:
Rilvegostomig
Description:
Experimental therapy by intravenous infusion
Arm group label:
Trastuzumab deruxtecan + rilvegostomig
Intervention type:
Diagnostic Test
Intervention name:
Agilent HercepTest™ mAb pharmDx
Description:
A semi-quantitative immunohistochemical assay to determine HER2 overexpression in FFPE
breast cancer tissues routinely processed for histological evaluation.
Based on a primary monoclonal rabbit antibody which visualises Her2 overexpression
utilising a fully automated IHC platform (Dako Omnis).
Arm group label:
Standard of Care
Arm group label:
Trastuzumab deruxtecan
Arm group label:
Trastuzumab deruxtecan + rilvegostomig
Intervention type:
Diagnostic Test
Intervention name:
Ventana PD-L1 SP263 assay
Description:
A qualitative immunohistochemical assay to determine the level of PD-L1 expression in
FFPE non-small cell lung cancer (NSCLC) tissues routinely processed for histological
evaluation. Based on a rabbit monoclonal anti-PD-L1 clone SP263 which visualises PD-L1
protein using a VENTANA BenchMark ULTRA instrument
Arm group label:
Standard of Care
Arm group label:
Trastuzumab deruxtecan
Arm group label:
Trastuzumab deruxtecan + rilvegostomig
Summary:
The purpose of this study is to measure the efficacy and safety of T-DXd with
rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and
durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Participants must be ≥ 18 years of age at the time of screening. Other age
restrictions may apply as per local regulations;
- Male and female;
- Unresectable, previously untreated, locally advanced or metastatic BTC. Prior
treatment in the perioperative and/or adjuvant setting is permissible provided there
is > 6 months (180 days) between the end of adjuvant treatment and the diagnosis of
locally advanced or metastatic disease.
- histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC;
- Provision of FFPE tumor sample that is no older than 3 years;
- At least one target lesion assessed by the Investigator based on RECIST v1.1
(randomized portion only);
- WHO/ECOG performance status of 0 or 1;
- Adequate organ and bone marrow function within 14 days before randomization;
- Evidence of post-menopausal status or negative serum pregnancy test for females of
childbearing potential;
Key Exclusion Criteria:
- Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors
and therapeutic anticancer vaccines;
- histologically confirmed ampullary carcinoma;
- history of substance abuse or any other medical conditions such as clinically
significant cardiac or psychological conditions;
- spinal cord compression or clinically active central nervous system metastases,
defined as untreated and symptomatic, or requiring therapy with corticosteroids or
anticonvulsants to control associated symptoms;
- medical history of myocardial infarction within 6 months before
randomization/enrollment, symptomatic congestive heart failure (New York Heart
Association Class II to IV), unstable angina pectoris, clinically important cardiac
arrhythmias, or a recent (< 6 months) cardiovascular event including stroke;
- Serious chronic gastrointestinal conditions associated with diarrhea (eg, active
inflammatory bowel disease); active non-infectious skin disease (including any grade
rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment;
- active autoimmune, connective tissue or inflammatory disorders that has required
systemic treatment in the past 2 years, or where there is documented, or a suspicion
of pulmonary involvement at the time of screening;
- Corrected QT interval (QTcF) prolongation to > 470 msec (females) or > 450 msec
(males) based on average of the screening triplicate 12-lead ECG;
- History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where
suspected ILD/pneumonitis cannot be ruled out by imaging at screening;
- Lung-specific intercurrent clinically significant illnesses including, but not
limited to, any underlying pulmonary disorder;
- Prior pneumonectomy (complete);
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals;
- Active primary immunodeficiency, known uncontrolled active HIV infection or HCV;
- Pregnant or breastfeeding female patients, or patients who are planning to become
pregnant;
- Participation in another clinical study with a study intervention or investigational
medicinal device administered in the last 6 months prior to randomization, or
concurrent enrollment in another clinical study, unless it is an observational
(non-interventional) clinical study or during the follow-up period of an
interventional study (only randomized portion).
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tucson
Zip:
85710
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fullerton
Zip:
92835
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Glendale
Zip:
91204
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Atlanta
Zip:
30309
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Niles
Zip:
60714
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Albuquerque
Zip:
87102
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Linz
Zip:
4010
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Wiener Neustadt
Zip:
2700
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Natal
Zip:
59012-300
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
90035-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
91350-200
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
05652-9000
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Vitória
Zip:
29043-272
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Halifax
Zip:
B3H 1V7
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brampton
Zip:
L6R 3J7
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H3A 1A1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bengbu
Zip:
233060
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230601
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nantong
Zip:
226001
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shandong
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200001
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
201114
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Brno
Zip:
656 53
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hradec Kralove
Zip:
500 05
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Olomouc
Zip:
77900
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Praha 10
Zip:
100 34
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Praha 5
Zip:
150 06
Country:
Czechia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Dresden
Zip:
01370
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Freiburg
Zip:
79106
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Göttingen
Zip:
37075
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hamburg
Zip:
22763
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Köln
Zip:
50937
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Leipzig
Zip:
4103
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Lübeck
Zip:
23538
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Munchen
Zip:
81377, DE
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Not yet recruiting
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Name:
Research Site
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Status:
Not yet recruiting
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Name:
Research Site
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Naples
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Napoli
Zip:
80128
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Roma
Zip:
00133
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tricase
Zip:
73039
Country:
Italy
Status:
Not yet recruiting
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Name:
Research Site
Address:
City:
Kashiwa
Zip:
227-8577
Country:
Japan
Status:
Recruiting
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Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Suita-city
Zip:
565-0871
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
George Town
Zip:
10990
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Johor Bahru
Zip:
81100
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kuala Lumpur
Zip:
50586
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kuala Lumpur
Zip:
59100
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Makati
Zip:
1229
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pasig City
Zip:
1605
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Quezon City
Zip:
1112
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Białystok
Zip:
15-027
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Katowice
Zip:
40-514
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
31-501
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Lublin
Zip:
20-081
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Warszawa
Zip:
02-034
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Wrocław
Zip:
50-556
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ar Riyāḑ
Zip:
11426
Country:
Saudi Arabia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Dammam
Zip:
31444
Country:
Saudi Arabia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Riyadh
Zip:
11525
Country:
Saudi Arabia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Riyadh
Zip:
12713
Country:
Saudi Arabia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Banska Bystrica
Zip:
974 01
Country:
Slovakia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bratislava
Zip:
833 10
Country:
Slovakia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kosice
Zip:
041 91
Country:
Slovakia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Martin
Zip:
036 59
Country:
Slovakia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Trnava
Zip:
917 75
Country:
Slovakia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
833
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hat Yai
Zip:
90110
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Khon Kaen
Zip:
40002
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Muang
Zip:
50200
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Mueang
Zip:
47000
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Naimuang
Zip:
30000
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ongkharak
Zip:
26120
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sisaket
Zip:
33000
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hanoi
Zip:
100000
Country:
Vietnam
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ho Chi Minh
Zip:
700000
Country:
Vietnam
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Vinh
Zip:
460000
Country:
Vietnam
Status:
Not yet recruiting
Start date:
August 12, 2024
Completion date:
May 16, 2029
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06467357
