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

Bio-Thera Solutions

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

BAT8006 for InjectionDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The maximum tolerated dose (MTD) and/or identify the recommended Phase 2 dose (RP2D) of BAT8006

Incidence of dose-limiting toxicities (DLTs)

Time frame: At the end of Cycle 1 (each cycle is 21 days)

The tolerability of BAT8006

Frequency and duration of dose interruptions and reductions

Time frame: 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

Time frame: From signed ICF to 30 days after the last drug administration

Physical examination

Number of participants with abnormal physical examination findings

Time frame: From signed ICF to 30 days after the last drug administration

ECOG

Changes in ECOG score

Time frame: From signed ICF to 30 days after the last drug administration

Vital signs

Number of participants with abnormal vital signs

Time frame: From signed ICF to 30 days after the last drug administration

Laboratory testings

Number of participants with abnormal laboratory testing results

Time frame: From signed ICF to 30 days after the last drug administration

Electrocardiogram（ ECG ）

Number of participants with abnormal ECG results

Time frame: From signed ICF to 30 days after the last drug administration

Data from ClinicalTrials.gov

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Secondary Outcomes

The immunogenicity of BAT8006

Specification and quantification of ADAs or NAb

Time frame: 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 \[PR\]

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: From signed ICF to 30 days after the last drug administration

The pharmacokinetics (PK) profile of BAT8006（Maximum concentration (Cmax)）

Maximum concentration (Cmax)

Time frame: 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)）

Time of Cmax (Tmax)

Time frame: 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)）

Area under the curve (AUC)

Time frame: 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)）

Terminal half-life (t½)

Time frame: 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