Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06635824




Registration number
NCT06635824
Ethics application status
Date submitted
8/10/2024
Date registered
10/10/2024
Date last updated
10/06/2025

Titles & IDs
Public title
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
Scientific title
A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)
Secondary ID [1] 0 0
2024-512998-27-00
Secondary ID [2] 0 0
GCT1046-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PD-L1-positive Metastatic NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Acasunlimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Docetaxel

Experimental: Arm A - Acasunlimab, 100 mg and pembrolizumab, 400 mg will be administered via intravenous (IV) infusion, once every 6 weeks (Q6W) (Cycle length=42 days).

Active comparator: Arm B - Docetaxel, 75 mg/m\^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days).


Treatment: Drugs: Acasunlimab
IV infusion

Treatment: Drugs: Pembrolizumab
IV infusion

Treatment: Drugs: Docetaxel
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Confirmed Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [4] 0 0
From first dose until the end of the study (approximately 5 years)
Secondary outcome [5] 0 0
Time to Treatment Discontinuation Due to AE
Timepoint [5] 0 0
From first dose until the end of the study (approximately 5 years)
Secondary outcome [6] 0 0
Plasma Concentration of Acasunlimab
Timepoint [6] 0 0
Predose and postdose at multiple timepoints in Cycles 1-4, then every other cycle starting Cycle 5 (Cycle length=42 days), up to approximately 5 years
Secondary outcome [7] 0 0
Number of Participants With Anti-drug Antibodies (ADAs) to Acasunlimab
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy Item GP5 (FACIT-GP5; Version 4) Score
Timepoint [8] 0 0
Baseline up to approximately 2 years
Secondary outcome [9] 0 0
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timepoint [9] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
Key

* Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV with known subtype).
* Participant has progressed radiographically on or after receiving:

* One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting; OR
* No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the metastatic disease setting.
* Participant must have positive tumor PD-L1 expression (tumor cells =1%) determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory.
* Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
* Participant has a life expectancy of =3 months.
* Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test.

* Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies.
* Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
* Prior treatment with docetaxel for NSCLC.
* Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
* Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2029
Actual
Sample size
Target
702
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Chris OBrien LifeHouse - Camperdown
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Ballarat Oncology & Haematology Service - Wendouree
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
South Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
Argentina
State/province [12] 0 0
La Rioja
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussels
Country [15] 0 0
Belgium
State/province [15] 0 0
Bruxelles
Country [16] 0 0
Belgium
State/province [16] 0 0
Gilly
Country [17] 0 0
Belgium
State/province [17] 0 0
Mechelen
Country [18] 0 0
Belgium
State/province [18] 0 0
Roeselare
Country [19] 0 0
Brazil
State/province [19] 0 0
Paraná
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio Grande Do Sul
Country [21] 0 0
Brazil
State/province [21] 0 0
Rio Grande Do Su
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Brazil
State/province [22] 0 0
Sao Paulo
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Brazil
State/province [23] 0 0
Belo Horizonte
Country [24] 0 0
Brazil
State/province [24] 0 0
Porto Alegre
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Brazil
State/province [25] 0 0
Rio de Janeiro
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Brazil
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Santo Andre
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Bulgaria
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Pleven
Country [28] 0 0
Bulgaria
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Plovdiv
Country [29] 0 0
Bulgaria
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Sofia
Country [30] 0 0
Chile
State/province [30] 0 0
Providencia
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Chile
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Santiago
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Chile
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Vina del Mar
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Croatia
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Dubrovnik
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Croatia
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Rijeka
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Estonia
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Tartu
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France
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Vaculuse
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France
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Val De Marne
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France
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Angers
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France
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Bayonne
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France
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Boulogne Billancourt
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France
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Creteil Cedex
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France
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Lille Cedex
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France
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Lyon Cedex
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France
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Marseille
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France
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Mulhouse
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France
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Nantes
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France
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Paris
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France
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Rennes
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France
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Saint Herblain
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France
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Toulon
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Greece
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Athens
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Greece
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Larissa
Country [53] 0 0
Greece
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Thessaloniki
Country [54] 0 0
Ireland
State/province [54] 0 0
Dublin
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Italy
State/province [55] 0 0
Milano
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Italy
State/province [56] 0 0
Torino
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Italy
State/province [57] 0 0
Candiolo
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Italy
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Genova
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Italy
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Meldola
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Italy
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Ravenna
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Italy
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Verona
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Japan
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Ehime-Ken
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Japan
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Osaka-Fu
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Fukuoka-shi
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Japan
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Hokkaido
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Japan
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Koto City
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Japan
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Kurashiki-shi
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Japan
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Kurume-shi
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Japan
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Nagoya-shi
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Japan
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Nagoya
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Japan
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Natori-shi
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Japan
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Okayama
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Japan
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Osaka-shi
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Osaka
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Japan
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Ota-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Harderwijk
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Netherlands
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Leiden
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Netherlands
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Nijmegen
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Netherlands
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Utrecht
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Netherlands
State/province [89] 0 0
Zwolle
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Poland
State/province [90] 0 0
Krakow
Country [91] 0 0
Poland
State/province [91] 0 0
Lodz
Country [92] 0 0
Poland
State/province [92] 0 0
Warszawa
Country [93] 0 0
Puerto Rico
State/province [93] 0 0
San Juan
Country [94] 0 0
Spain
State/province [94] 0 0
Córdoba
Country [95] 0 0
Spain
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Madrid
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Spain
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Málaga
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Malaga
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Spain
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Valencia
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Taiwan
State/province [102] 0 0
Douliu
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Taiwan
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Tainan
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Taiwan
State/province [104] 0 0
Taipei
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Taiwan
State/province [105] 0 0
Taoyuan City
Country [106] 0 0
United Kingdom
State/province [106] 0 0
London
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Nottingham
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genmab
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Official
Address 0 0
Genmab
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Genmab Trial Information
Address 0 0
Country 0 0
Phone 0 0
+4570202728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06635824