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Recruiting Phase 3 NCT07522073

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Phase 3 – large-scale trial before approval
Conditions: Solid Tumors

Sponsor: Incyte Corporation

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Who can participate
Inclusion Criteria: * Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation * No prior systemic treatment in the metastatic setting * ECOG Performance status 0-1 * Adequate organ function Exclusion Criteria: * Prior treatment with any KRAS inhibitor * Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug * Known active CNS metastases Other protocol-defined Inclusion/Exclusion Criteria may apply.
Locations 17
Australia (1)
Investigative Site AU007
Liverpool , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Investigative Site BE008
Anderlecht
NOT_YET_RECRUITING
Canada (1)
Investigative Site CA001
Toronto , Ontario
NOT_YET_RECRUITING
Denmark (1)
Investigative Site DK006
Aalborg
NOT_YET_RECRUITING
Finland (1)
Investigative Site FI001
Helsinki
NOT_YET_RECRUITING
France (1)
Investigative Site FR013
Brest
NOT_YET_RECRUITING
Italy (1)
Investigative Site IT002
Bologna
NOT_YET_RECRUITING
Japan (1)
Investigative Site JP002
Kashiwa-shi
NOT_YET_RECRUITING
Netherlands (1)
Investigative Site NL001
Amsterdam
NOT_YET_RECRUITING
Norway (1)
Investigative Site NO002
Bergen
NOT_YET_RECRUITING
Poland (1)
Investigative Site PL008
Gdansk
NOT_YET_RECRUITING
Puerto Rico (1)
Investigative Site PR001
Dorado
South Korea (1)
Investigative Site KR004
Goyang-si
NOT_YET_RECRUITING
Spain (1)
Investigative Site ES011
Badalona
NOT_YET_RECRUITING
Sweden (1)
Investigative Site SE003
Linköping
NOT_YET_RECRUITING
United Kingdom (1)
Investigative Site GB008
Dundee
NOT_YET_RECRUITING
United States (1)
Investigative Site US058
Birmingham , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
09.04.2026
Completion date
19.03.2029
Registry ID
NCT07522073
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.