A Study of ADRX-0706 in Select Advanced Solid Tumors

Running, not enrolling · Phase 1

Conditions studied: Solid Tumors, Triple Negative Breast Cancer (TNBC), Urothelial Cancer, Cervical Cancer

In brief

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.

Key facts

Study ID

NCT06036121

Run by

Adcentrx Therapeutics

People needed

144

Starts

2023-09-26

Expected to finish

2026-12-01

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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