A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer
NCT Number: NCT06545617
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Platinum-resistant Epithelial Ovarian Cancer|Fallopian Tube Cancer|Primary Peritoneal Cancer
Interventions: DRUG: BAT8006 for Injection
Sponsor: Bio-Thera Solutions
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-04
Completion Date: 2028-01-31

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

Primary Outcome Measures: The maximum tolerated dose (MTD) and/or identify the recommended Phase 2 dose (RP2D) of BAT8006, Incidence of dose-limiting toxicities (DLTs), At the end of Cycle 1 (each cycle is 21 days)|The tolerability of BAT8006, Frequency and duration of dose interruptions and reductions, From date of first dose administration until the date of clinical progression, adverse event, physician decisionor or date of death from any cause, whichever came first, assessed at most up to 27 months|Adverse events（AE）, Include SAEs, TEAEs, From signed ICF to 30 days after the last drug administration|Physical examination, Number of participants with abnormal physical examination findings, From signed ICF to 30 days after the last drug administration|ECOG, Changes in ECOG score, From signed ICF to 30 days after the last drug administration|Vital signs, Number of participants with abnormal vital signs, From signed ICF to 30 days after the last drug administration|Laboratory testings, Number of participants with abnormal laboratory testing results, From signed ICF to 30 days after the last drug administration|Electrocardiogram（ ECG ）, Number of participants with abnormal ECG results, From signed ICF to 30 days after the last drug administration|Echo/MUGA, Number of participants with abnormal Echo/MUGA results, From signed ICF to 30 days after the last drug administration|Ophthalmologic findings, Number of participants with abnormal ophthalmologic findings, From signed ICF to 30 days after the last drug administration
Secondary Outcome Measures: The immunogenicity of BAT8006, Specification and quantification of ADAs or NAb, Pre-dose of Cycle 1 to Cycle 1 Day 15, Pre-dose of Cycle 2, 4 until every 4 cycles|Objective response rate (ORR), The proportion of subjects who achieved a confirmed response of complete response (CR) or partial response \[PR\], From signed ICF to 30 days after the last drug administration|Duration of response (DOR), The time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD), From signed ICF to 30 days after the last drug administration|Best percent change in the sum of the longest diameters (SLD) of measurable tumors, Best percent change in the sum of the longest diameters (SLD) of measurable tumors according to RECIST v1.1, From signed ICF to 30 days after the last drug administration|Progression-free survival (PFS), The time from the date of randomization/registration to the earlier of the dates of the first objective documentation of radiographic PD via independent radiologic facility review based on RECIST version 1.1 or death due to any cause, From signed ICF to 30 days after the last drug administration|The pharmacokinetics (PK) profile of BAT8006, Maximum concentration (Cmax), Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1|The pharmacokinetics (PK) profile of BAT8006, Time of Cmax (Tmax), Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1|The pharmacokinetics (PK) profile of BAT8006, Area under the curve (AUC), Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1|The pharmacokinetics (PK) profile of BAT8006, Terminal half-life (t½), Cycle 1 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 2 Day 1; Cycle 3 Day 1, 2, 3, 4, 8, 15, 22 to Cycle 4/6/8/12/16/20/24/28/32 Day 1