Open
Actively Recruiting
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
24-6071
Category
Prostate Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood