A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer
Summary
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
Arms & interventions
- BiologicalJANX014
JANX014 will be administered via IV dosing
Outcome measures
Primary
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: 2 years
Incidence of adverse events (AE) and Serious Adverse Events (SAE)
Time frame: 2 years
Secondary
Area under the curve from time 0 to t of JANX014 (AUC0-t)
Time frame: up to 2 years
Maximum observed concentration of JANX014 (Cmax)
Time frame: up to 2 years
Number of participants who develop anti-drug antibodies against JANX014
Time frame: up to 2 years
Prostate Specific Antigen (PSA) response
Time frame: up to 2 years
Overall Response Rate
Time frame: up to 2 years
Duration of Response
Time frame: up to 2 years
Radiographic Progression Free Survival (rPFS)
Time frame: up to 2 years
Eligibility criteria
Study locations (1)
Research Site
Nashville, Tennessee, 37203