Actively Recruiting
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
Led by Adcentrx Therapeutics · Updated on 2025-04-09
68
Participants Needed
8
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with histologically confirmed select advanced solid tumors including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer (Phase 1a dose escalation)
- Subjects with histologically confirmed prostate adenocarcinoma that is castration resistant and intolerant or resistant to standard of care therapies (Phase 1b dose expansion)
- Measurable disease per RECIST version 1.1 or evaluable disease by PCWG3 criteria for prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 for Phase 1a and 0-2 for Phase 1b
- Adequate hematologic, liver, and renal function
You will not qualify if you...
- Active and uncontrolled central nervous system metastases
- Significant cardiovascular disease
- History of another malignancy within 3 years except the one treated in this study
- Receipt of any anticancer or investigational therapy within 5 elimination half-lives or 14 days; 4 weeks for therapeutic radiopharmaceuticals for prostate cancer
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids within 2 years, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out by imaging
- Receiving systemic antimicrobial treatment for active infection (routine prophylaxis permitted)
AI-Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UCLA
Santa Monica, California, United States, 90404
Actively Recruiting
3
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
4
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
6
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
8
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Adcentrx Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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