ACTIVE_NOT_RECRUITING

A Study of ADRX-0706 in Select Advanced Solid Tumors

Talk to us

Conditions

Solid TumorsTriple Negative Breast Cancer (TNBC)Urothelial CancerCervical Cancertriple negative breast cancerADC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors

Quick Facts

Study Start:2023-09-26
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06036121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Measurable disease according to RECIST version 1.1
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. * Adequate hematologic, liver, and renal function
  1. * Active and uncontrolled central nervous system metastases
  2. * Significant cardiovascular disease
  3. * History of another malignancy other than the one for which the subject is being treated on this study within 3 years
  4. * Receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days (whichever is less)
  5. * Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug
  6. * Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Contacts and Locations

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
UCLA
Los Angeles, California, 90404
United States
Comprehensive Hematology Oncology
Saint Petersburg, Florida, 33709
United States
Moffitt Cancer Center
Tampa, Florida, 33610
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Cancer
Detroit, Michigan, 48202
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
The Ohio State University Wexner Medical Center
Hilliard, Ohio, 43026
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Sarah Cannon Cancer Network
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
START San Antonio
San Antonio, Texas, 78229
United States
START Mountain Region
West Valley City, Utah, 84119
United States

Collaborators and Investigators

Sponsor: Adcentrx Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-26
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-09-26
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • urothelial cancer
  • triple negative breast cancer
  • cervical cancer
  • ADC

Additional Relevant MeSH Terms

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