Testing ADRX-0405 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, and pharmacokinetics of ADRX-0405 in patients with select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. The study is divided into two parts: Phase 1a focuses on dose escalation to determine the recommended dose, while Phase 1b assesses the safety and preliminary efficacy of the optimal dose in patients with previously treated metastatic castration resistant prostate cancer. Participants will undergo monitoring for adverse effects and treatment response throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).
* 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.
* Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b
* 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); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer
* 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.
* Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• UCLA
  Santa Monica, California, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• University of Minnesota Masonic Cancer Center
  Minneapolis, Minnesota, United States Recruiting
• NEXT Austin
  Austin, Texas, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Adcentrx Therapeutics
• Email: clinicaltrials@adcentrx.com
• Phone: 858-428-9502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.