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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Adcentrx Therapeutics · Participants: 68 · Started: Dec 30, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06710379

Locations in the U.S.

CaliforniaCity of Hope, Duarte
UCLA, Santa Monica
MichiganSTART Midwest, Grand Rapids
MinnesotaUniversity of Minnesota Masonic Cancer Center, Minneapolis
TexasNEXT Austin, Austin
The University of Texas MD Anderson Cancer Center, Houston
UtahSTART Mountain Region, West Valley City
VirginiaNEXT Virginia, Fairfax

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.