A Study of ADRX-0706 in Select Advanced Solid Tumors

NCT ID: NCT06036121

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-26

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0706 in patients with urothelial cancer, triple negative breast cancer, and cervical cancer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumors Triple Negative Breast Cancer (TNBC) Urothelial Cancer Cervical Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase 1a Dose Escalation

Increasing 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.

Group Type EXPERIMENTAL

ADRX-0706

Intervention Type DRUG

Antibody drug conjugate targeting Nectin-4

Phase 1b Dose Expansion

ADRX-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.

Group Type EXPERIMENTAL

ADRX-0706

Intervention Type DRUG

Antibody drug conjugate targeting Nectin-4

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADRX-0706

Antibody drug conjugate targeting Nectin-4

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Adcentrx Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

UCLA

Los Angeles, California, United States

Site Status

Comprehensive Hematology Oncology

St. Petersburg, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Cancer

Detroit, Michigan, United States

Site Status

START Midwest

Grand Rapids, Michigan, United States

Site Status

The Ohio State University Wexner Medical Center

Hilliard, Ohio, United States

Site Status

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Sarah Cannon Cancer Network

Nashville, Tennessee, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

START San Antonio

San Antonio, Texas, United States

Site Status

START Mountain Region

West Valley City, Utah, United States

Site Status

Beijing University Third Hospital

Beijing, , China

Site Status

Fujian Cancer Hospital

Fujian, , China

Site Status

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status

Hunan Cancer hospital

Hunan, , China

Site Status

Shandong Cancer Hospital

Jinan, , China

Site Status

Shanghai East Hospital

Shanghai, , China

Site Status

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status

Wuhan Union Hospital

Wuhan, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ADRX-0706-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.