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

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

Study Overview

• Status: Withdrawn
• Conditions: Fallopian Tube Cancer; Primary Peritoneal Cancer; Platinum-resistant Epithelial Ovarian Cancer
• Intervention / Treatment: Drug: BAT8006 for Injection

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1; BAT8006 for Injection does according to protocol (frequency: Q3W)	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.; Other Names: Recombinant humanized anti-FRα monoclonal antibody-Exatecan conjugate
Active Comparator: Cohort 2; BAT8006 for Injection does according to protocol (frequency: Q3W)	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.; Other Names: Recombinant humanized anti-FRα monoclonal antibody-Exatecan conjugate
Active Comparator: Cohort 3; BAT8006 for Injection does according to protocol (frequency: Q3W)	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.; Other Names: Recombinant humanized anti-FRα monoclonal antibody-Exatecan conjugate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)）	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)）	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)）	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)）	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

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions
• Investigators: Principal Investigator: Kathleen Moore, The University of Oklahoma College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): March 10, 2026
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Adnexal Diseases; Genital Neoplasms, Female; Fallopian Tube Diseases; Fallopian Tube Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: BAT-8006-002-CR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No