RECRUITING

A Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors

Talk to us

Conditions

Solid Tumors

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-0405 in patients with select advanced solid tumors.

Official Title

A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors

Quick Facts

Study Start:2024-12
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06710379

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 metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC).
  2. * Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone \< 50 ng/dL \[\< 2.0 nM\]) and that is intolerant/resistant to standard of care (SOC) therapies.
  3. * Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b
  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); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer
  5. * History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  6. * Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Contacts and Locations

Study Contact

Adcentrx Therapeutics
CONTACT
858-428-9502
clinicaltrials@adcentrx.com

Study Locations (Sites)

START Midwest
Grand Rapids, Michigan, 49546
United States
NEXT Austin
Austin, Texas, 78758
United States
START Mountain Region
West Valley City, Utah, 84119
United States
NEXT Virginia
Fairfax, Virginia, 22031
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 Date2024-12
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors