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A Study of ADRX-0405 for Advanced Solid Tumors

This study is testing a new drug called ADRX-0405 in people with certain advanced solid tumors, including metastatic castration-resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC). ADRX-0405 is an antibody-drug conjugate, which means it's designed to deliver a drug directly to cancer cells that have a specific target called STEAP1. The main goal of this study is to find out how safe ADRX-0405 is, how well people tolerate it, and to determine the best dose. The study is currently recruiting up to 68 participants. Success will be measured by tracking any side effects experienced by participants until the study ends, which is estimated to be about two years.

Study design
This is a two-part study that will enroll up to 68 participants. The first part will test different doses of ADRX-0405 to find a safe and effective amount.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to track any side effects until the study is completed, which is estimated to be two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06710379

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Adcentrx Therapeutics
~68 participants
Updated 2025-04-09 on ClinicalTrials.gov
What's tested:ADRX-0405

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Until study completion (estimated 2 years)

Conditions

Solid Tumors

Explore related trials

Gastric CarcinomaLung Non-Small Cell CarcinomaProstate CarcinomaSolid Neoplasm

Where it's being run

8 sites across 6 states
California2
Texas2
Michigan1
Minnesota1
Utah1
Virginia1

Who to contact

Adcentrx Therapeutics
[email protected]
858-428-9502
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of adverse eventsUntil study completion (estimated 2 years)