Product information and disease descriptionProduct descriptionProduct information
Special populations
2 evidence topics · 2 sources
Age, hepatic disease, and other eligibility restrictions in the phase 1/2 trial
| Criterion | Quoted record |
|---|---|
| Minimum age | “18 Years” |
| Performance status | “Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1” |
| Liver disease | “History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.” |
| Central nervous system metastases | “Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.” |
| Cardiovascular disease | “Clinically significant cardiovascular disease” |
| Ocular disease | “Active keratitis (inflammation of the cornea of the eye)” |
| Prior auristatin ADC | “Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.” |
| Prior B7-H4 therapy | “Prior B7-H4 targeted treatment.” |
Pediatric use, pregnancy and lactation, renal impairment, and hepatic impairment pharmacokinetics
No evidence found.