NCT06545617

A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer

A Phase 1b/2, Multicenter, Open-Label Study of BAT8006, an Anti- FRα Antibody Drug Conjugate (ADC) for Platinum-resistant Ovarian Cancer Subjects

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b/2, open-label, 2-part, global study designed to investigate the anti-tumor activity as well as the safety and efficacy of BAT8006 in subjects with platinum resistance ovarian cancer

Detailed description

Part 1 is a Dose Finding Study. The RP2D will be confirmed in Part 1, and this RP2D will be further evaluated in Part 2. In Part 1, PK samples will be collected and analyzed to support the determination of RP2D. Three dose cohorts are planned. Subjects will be assigned to these three dosages in parallel. Part 2 will expose subjects at the RP2D confirmed in Part 1.

Conditions

• Platinum-resistant Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	BAT8006 for Injection	Intravenous infusion: once every three weeks.The infusion time in the first cycle is recommended to be ≥ 90 minutes. If no infusion reaction occurs, the subsequent cycle can be completed within 30\~60 minutes.

Timeline

• Start date: 2025-01-31
• Primary completion: 2026-03-10
• Completion: 2028-01-31
• First posted: 2024-08-09
• Last updated: 2026-01-07

Regulatory

• FDA-regulated drug study