DISCLAIMER

The contents of the presentations above are designed for educational and scientific exchange purposes and are not promotional. They may contain information on investigational products or investigational uses of approved products. No conclusions regarding safety and/or efficacy for such investigational products or uses may be made.
 

SUMMARY

This presentation reported pharmacokinetic and exposure–response analyses from an ongoing first‑in‑human, multicenter Phase 1 study of BG‑C9074, an investigational B7‑H4–targeting topoisomerase I inhibitor antibody–drug conjugate (ADC), in patients with advanced solid tumors. Total body weight–based dosing (1–7 mg/kg) and adjusted ideal body weight–based dosing (6.5–9 mg/kg) were evaluated with intravenous administration every three weeks. Pharmacokinetic samples were collected at Cycle 1 and at steady state to assess ADC and plasma free payload exposure. As of October 30, 2025, data was available for 107 patients. Total body weight–based dosing was associated with a maximum tolerated dose below 7 mg/kg, with higher exposure observed in patients with higher body weight. ADC clearance increased moderately with body weight, contributing to greater exposure in higher‑weight patients. Higher exposure was associated with an increased incidence of Grade ≥3 treatment‑related adverse events, predominantly neutropenia. Adjusted ideal body weight–based dosing enabled administration at 8 mg/kg by normalizing ADC and payload exposure across body‑weight ranges.
 

ClinicalTrials.gov ID: NCT06233942