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

NCT06545617 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: BAT-8006-002-CR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (9)

• The immunogenicity of BAT8006

  Pre-dose of Cycle 1 to Cycle 1 Day 15, Pre-dose of Cycle 2, 4 until every 4 cycles

• Objective response rate (ORR)

  From signed ICF to 30 days after the last drug administration

• Duration of response (DOR)

  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

  From signed ICF to 30 days after the last drug administration

• Progression-free survival (PFS)

  From signed ICF to 30 days after the last drug administration

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

BAT8006 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8006 for Injection

Cohort 2

ACTIVE COMPARATOR

BAT8006 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8006 for Injection

Cohort 3

ACTIVE COMPARATOR

BAT8006 for Injection does according to protocol (frequency: Q3W)

Drug: BAT8006 for Injection

Interventions

BAT8006 for Injection DRUG

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.

Also known as: Recombinant humanized anti-FRα monoclonal antibody-Exatecan conjugate

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Females who are pregnant or nursing.
• Had major surgery within 28 days of the Screening visit.
• History of autologous transplantation ≤ 3 months
• 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.
• History of human immunodeficiency virus (HIV) infection.
• Active hepatitis B or C.
• Any other serious underlying medical.
• Received cancer-directed therapy within the timeframes.
• Subjects have other active malignancies within 5 years prior to the first dose.
• Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
• Vaccinated with any live-attenuated vaccine within 4 weeks.
• Subjects with known history of psychiatric disorders, drug abuse, alcoholism or drug addiction.
• 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.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Kathleen Moore

  The University of Oklahoma College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 9, 2024
• Study Start: January 31, 2025
• Primary Completion: March 10, 2026
• Study Completion (Estimated): January 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01