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Active, not recruiting Phase 1

A Study of ADRX-0706 in Select Advanced Solid Tumors

NCT06036121 · tracked via the Priya Life Science USA tracker
Sponsor
Adcentrx Therapeutics
Phase
Phase 1
Started
2023-09-26
Last updated
2025-08-17

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
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

More Adcentrx Therapeutics trials in the USA

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