eligibility_summary
Inclusion: Phase 1a: advanced solid tumors (mCRPC, GC, NSCLC). Phase 1b: mCRPC (prostate adenocarcinoma) castration-resistant (<50 ng/dL) and SOC-intolerant/resistant. Measurable/evaluable disease (RECIST 1.1 or PCWG3). ECOG 0–1 (1a), 0–2 (1b). Adequate organ function. Exclusion: uncontrolled CNS mets, significant CV disease, other recent cancer (<3y), recent therapy (≤5 half-lives/14 d, radiopharmaceuticals <4 w), ILD/pneumonitis, active infection needing antibiotics.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1a/1b study of ADRX-0405 in advanced solid tumors with expansion in mCRPC. Intervention: ADRX-0405, a STEAP1-targeted antibody–drug conjugate (ADC). Mechanism of action: a monoclonal antibody binds STEAP1 on tumor cells and delivers a cytotoxic payload after internalization, leading to selective tumor cell kill. Drug type: targeted immunotherapy/ADC. Cells/pathways targeted: STEAP1-expressing tumor cells (notably in metastatic castration-resistant prostate cancer, also evaluated in gastric cancer and NSCLC). Primary objectives: characterize safety, tolerability, pharmacokinetics, and identify MTD/recommended dose.