Phase
Condition
Cervical Cancer
Neoplasms
Vaginal Cancer
Treatment
ADRX-0706
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Phase 1a Dose Escalation: Subjects with histologically confirmed select advancedsolid tumors, including urothelial carcinoma (UC), head and neck squamous cellcarcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small celllung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least oneprior systemic regimen and have no other therapy available known to providemeaningful clinical benefit in the opinion of the investigator.
Phase 1b Dose Expansion: Subjects with urothelial cancer, triple negative breastcancer or cervical cancer with disease progression after at least one prior systemicregimen and no standard treatment options available and considered appropriate inthe 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
Exclusion Criteria:
Active and uncontrolled central nervous system metastases
Significant cardiovascular disease
History of another malignancy other than the one for which the subject is beingtreated on this study within 3 years
Receipt of any anticancer or investigational therapy within 5 elimination half-livesor 14 days (whichever is less)
Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 daysprior to the first dose of study drug
Receiving systemic antimicrobial treatment for active infection; routineantimicrobial prophylaxis is permitted
Study Design
Study Description
Connect with a study center
Beijing University Third Hospital
Beijing,
ChinaSite Not Available
Fujian Cancer Hospital
Fujian,
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou,
ChinaSite Not Available
Hunan Cancer hospital
Hunan,
ChinaSite Not Available
Shandong Cancer Hospital
Jinan,
ChinaSite Not Available
Shanghai East Hospital
Shanghai,
ChinaSite Not Available
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan,
ChinaSite Not Available
Wuhan Union Hospital
Wuhan,
ChinaSite Not Available
UCLA
Los Angeles, California 90404
United StatesSite Not Available
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
Comprehensive Hematology Oncology
Saint Petersburg, Florida 33709
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33610
United StatesSite Not Available
Henry Ford Cancer
Detroit, Michigan 48202
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
START Midwest
Grand Rapids, Michigan 49546
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Hillard, Ohio 43026
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Hilliard, Ohio 43026
United StatesSite Not Available
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Sarah Cannon Cancer Network
Nashville, Tennessee 37203
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
START San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
START Mountain Region
West Valley City, Utah 84119
United StatesSite Not Available

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