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A Study of ADRX-0706 in Select Advanced Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

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

NCT06036121•Adcentrx Therapeutics

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (21)

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

Key Dates

Start Date

September 26, 2023

Primary Completion Date

September 1, 2025

Completion Date

December 1, 2026

Last Updated

August 17, 2025

Enrollment

144

ESTIMATED participants

Conditions

Solid TumorsTriple Negative Breast Cancer (TNBC)Urothelial CancerCervical Cancer

Interventions

ADRX-0706

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ADRX-0706 in Select Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer