Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
144 participants
INTERVENTIONAL
2023-09-26
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Dose Escalation
Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.
ADRX-0706
Antibody drug conjugate targeting Nectin-4
Phase 1b Dose Expansion
ADRX-0706 will be initially administered to patients at the dose recommended from the Phase 1a part in 3 disease-specific cohorts: urothelial cancer, triple negative breast cancer, and cervical cancer.
ADRX-0706
Antibody drug conjugate targeting Nectin-4
Interventions
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ADRX-0706
Antibody drug conjugate targeting Nectin-4
Eligibility Criteria
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Inclusion Criteria
* Phase 1b Dose Expansion: Subjects with urothelial cancer, triple negative breast cancer or cervical cancer with disease progression after at least one prior systemic regimen and no standard treatment options available and considered appropriate in the opinion of the investigator, unless subject refuses standard therapy.
* Measurable disease according to RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, liver, and renal function
Exclusion Criteria
* Significant cardiovascular disease
* History of another malignancy other than the one for which the subject is being treated on this study within 3 years
* Receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days (whichever is less)
* Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug
* Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted
18 Years
ALL
No
Sponsors
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Adcentrx Therapeutics
INDUSTRY
Responsible Party
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Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Cancer
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
The Ohio State University Wexner Medical Center
Hilliard, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Cancer Network
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
START San Antonio
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
Beijing University Third Hospital
Beijing, , China
Fujian Cancer Hospital
Fujian, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
Hunan Cancer hospital
Hunan, , China
Shandong Cancer Hospital
Jinan, , China
Shanghai East Hospital
Shanghai, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Wuhan Union Hospital
Wuhan, , China
Countries
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Other Identifiers
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ADRX-0706-001
Identifier Type: -
Identifier Source: org_study_id
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