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

Phase 1

Not yet recruiting

• Conditions: Platinum-resistant Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
• Interventions: Drug: BAT8006 for Injection

• Registration Number: NCT06545617
• Lead Sponsor: Bio-Thera Solutions

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-31
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Study Start: 2025-01-31
• Primary Completion: 2026-03-10
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
2. Women ≥ 18 years old.
3. Subjects with histologically or cytologically confirmed platinum-resistant, advanced or metastatic epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
4. Presence of at least one measurable lesion per RECIST v1.1. that was not in a prior radiation or other locally treated area.
5. Life expectancy ≥ 3 months.
6. Adequate hematological, liver, kidney and coagulation function.

Exclusion Criteria

1. Females who are pregnant or nursing.
2. Had major surgery within 28 days of the Screening visit.
3. History of autologous transplantation ≤ 3 months
4. History of severe infection deemed clinically significant by the PI or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study drug.
5. History of human immunodeficiency virus (HIV) infection.
6. Active hepatitis B or C.
7. Any other serious underlying medical.
8. Received cancer-directed therapy within the timeframes.
9. Subjects have other active malignancies within 5 years prior to the first dose.
10. Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
11. Vaccinated with any live-attenuated vaccine within 4 weeks.
12. Subjects with known history of psychiatric disorders, drug abuse, alcoholism or drug addiction.
13. Subjects who are estimated by the investigator to have poor compliance with the clinical study or who have other factors that are not appropriate to participate in the study in the opinion of the investigator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	BAT8006 for Injection	BAT8006 for Injection does according to protocol (frequency: Q3W)
Cohort 3	BAT8006 for Injection	BAT8006 for Injection does according to protocol (frequency: Q3W)
Cohort 1	BAT8006 for Injection	BAT8006 for Injection does according to protocol (frequency: Q3W)

Primary Outcome Measures

Name	Time	Method
Ophthalmologic findings	From signed ICF to 30 days after the last drug administration	Number of participants with abnormal ophthalmologic findings
Echo/MUGA	From signed ICF to 30 days after the last drug administration	Number of participants with abnormal Echo/MUGA results
The maximum tolerated dose (MTD) and/or identify the recommended Phase 2 dose (RP2D) of BAT8006	At the end of Cycle 1 (each cycle is 21 days)	Incidence of dose-limiting toxicities (DLTs)
Laboratory testings	From signed ICF to 30 days after the last drug administration	Number of participants with abnormal laboratory testing results
Adverse events（AE）	From signed ICF to 30 days after the last drug administration	Include SAEs, TEAEs
Physical examination	From signed ICF to 30 days after the last drug administration	Number of participants with abnormal physical examination findings
Vital signs	From signed ICF to 30 days after the last drug administration	Number of participants with abnormal vital signs
Electrocardiogram（ ECG ）	From signed ICF to 30 days after the last drug administration	Number of participants with abnormal ECG results
The tolerability of BAT8006	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	Frequency and duration of dose interruptions and reductions
ECOG	From signed ICF to 30 days after the last drug administration	Changes in ECOG score

Secondary Outcome Measures

Name	Time	Method
The immunogenicity of BAT8006	Pre-dose of Cycle 1 to Cycle 1 Day 15, Pre-dose of Cycle 2, 4 until every 4 cycles	Specification and quantification of ADAs or NAb
Objective response rate (ORR)	From signed ICF to 30 days after the last drug administration	The proportion of subjects who achieved a confirmed response of complete response (CR) or partial response \[PR\]
Duration of response (DOR)	From signed ICF to 30 days after the last drug administration	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)
Best percent change in the sum of the longest diameters (SLD) of measurable tumors	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 according to RECIST v1.1
Progression-free survival (PFS)	From signed ICF to 30 days after the last drug administration	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
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	Maximum concentration (Cmax)
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	Time of Cmax (Tmax)
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	Area under the curve (AUC)
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	Terminal half-life (t½)