Clinical Trials in the USA / NCT06036121
Active, not recruiting
Phase 1
A Study of ADRX-0706 in Select Advanced Solid Tumors
NCT06036121 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Solid TumorsTriple Negative Breast Cancer (TNBC)Urothelial CancerCervical Cancer
Investigational drug(s) / intervention(s)
ADRX-0706
ADRX-0706: Antibody drug conjugate targeting Nectin-4
Study 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.
Eligibility
Inclusion Criteria:
* 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
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 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
Primary outcome measure(s)
- Incidence of adverse events — Until study completion (estimated 3 years)
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | |
| UCLA | Los Angeles | California | |
| Comprehensive Hematology Oncology | St. Petersburg | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Henry Ford Cancer | Detroit | Michigan | |
| START Midwest | Grand Rapids | Michigan | |
| The Ohio State University Wexner Medical Center | Hilliard | Ohio | |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | |
| Sarah Cannon Cancer Network | Nashville | Tennessee | |
| University of Texas MD Anderson Cancer Center | Houston | Texas | |
| START San Antonio | San Antonio | Texas | |
| START Mountain Region | West Valley City | Utah | |
| 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 |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06036121 on ClinicalTrials.gov ↗ ← All trials in the USA