A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
NCT ID: NCT06710379
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
68 participants
INTERVENTIONAL
2024-12-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Dose Escalation
Increasing doses of ADRX-0405 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.
ADRX-0405
Antibody Drug Conjugate targeting STEAP1
Phase 1b Dose Expansion
ADRX-0405 will be initially administered at the dose recommended from the Phase 1a part in subjects with previously treated mCRPC.
ADRX-0405
Antibody Drug Conjugate targeting STEAP1
Interventions
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ADRX-0405
Antibody Drug Conjugate targeting STEAP1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Adcentrx Therapeutics
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
UCLA
Santa Monica, California, United States
START Midwest
Grand Rapids, Michigan, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
NEXT Austin
Austin, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
START Mountain Region
West Valley City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ADRX-0405-001
Identifier Type: -
Identifier Source: org_study_id
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