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Clinical Trials in the USA / NCT06710379
Recruiting Phase 1

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

NCT06710379 · tracked via the Priya Life Science USA tracker
Sponsor
Adcentrx Therapeutics
Phase
Phase 1
Started
2024-12-30
Last updated
2025-04-09

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

ADRX-0405

ADRX-0405: Antibody Drug Conjugate targeting STEAP1

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
UCLA Santa Monica California Recruiting
START Midwest Grand Rapids Michigan Recruiting
University of Minnesota Masonic Cancer Center Minneapolis Minnesota Recruiting
NEXT Austin Austin Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting

More Adcentrx Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06710379 on ClinicalTrials.gov ↗ ← All trials in the USA