A Study of ADRX-0706 in Select Advanced Solid Tumors
A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors
1 other identifier
interventional
144
2 countries
21
Brief Summary
The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2023
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedAugust 17, 2025
August 1, 2025
1.9 years
September 6, 2023
August 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
Until study completion (estimated 3 years)
Secondary Outcomes (12)
Measurement of maximum plasma concentration (Cmax) of ADRX-0706
Until study completion (estimated 3 years)
Measurement of trough concentration (Ctrough) of ADRX-0706
Until study completion (estimated 3 years)
Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706
Until study completion (estimated 3 years)
Measurement of terminal half-life (t1/2) of ADRX-0706
Until study completion (estimated 3 years)
Measurement of systemic clearance (CL) of ADRX-0706
Until study completion (estimated 3 years)
- +7 more secondary outcomes
Study Arms (2)
Phase 1a Dose Escalation
EXPERIMENTALIncreasing 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.
Phase 1b Dose Expansion
EXPERIMENTALADRX-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.
Interventions
Antibody drug conjugate targeting Nectin-4
Eligibility Criteria
You may qualify if:
- Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator.
- 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
You may not qualify if:
- Active and uncontrolled central nervous system metastases
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA
Los Angeles, California, 90404, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709, United States
Moffitt Cancer Center
Tampa, Florida, 33610, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Cancer
Detroit, Michigan, 48202, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
The Ohio State University Wexner Medical Center
Hilliard, Ohio, 43026, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Sarah Cannon Cancer Network
Nashville, Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
START San Antonio
San Antonio, Texas, 78229, United States
START Mountain Region
West Valley City, Utah, 84119, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2023
First Posted
September 13, 2023
Study Start
September 26, 2023
Primary Completion
September 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share