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A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06710379.
