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Platinum-resistant Epithelial Ovarian CancerPhase 1/2NCT06545617

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

A Phase 1/2 study testing BAT8006 for Injection in people with Platinum-resistant Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Bio-Thera Solutions.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
BAT8006 for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Jan 2025to 31 Jan 2028
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

About this study

Official title: 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

Read the 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.

Being tested
BAT8006 for Injection
Medical subject headings
Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT8006 for InjectionDrug

    Also called Recombinant humanized anti-FRα monoclonal antibody-Exatecan conjugate

    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.

Study groups in NCT06545617
Study groupRoleWhat they receive
Cohort 1Active comparatorBAT8006 for Injection does according to protocol (frequency: Q3W)
Receives: Drug: BAT8006 for Injection
Cohort 2Active comparatorBAT8006 for Injection does according to protocol (frequency: Q3W)
Receives: Drug: BAT8006 for Injection
Cohort 3Active comparatorBAT8006 for Injection does according to protocol (frequency: Q3W)
Receives: Drug: BAT8006 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence of dose-limiting toxicities (DLTs)

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

  2. The tolerability of BAT8006

    Frequency and duration of dose interruptions and reductions

    Measured: 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

  3. Adverse events（AE）

    Include SAEs, TEAEs

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

  4. Physical examination

    Number of participants with abnormal physical examination findings

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

  5. ECOG

    Changes in ECOG score

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

  6. Vital signs

    Number of participants with abnormal vital signs

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

  7. Laboratory testings

    Number of participants with abnormal laboratory testing results

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

  8. Electrocardiogram（ ECG ）

    Number of participants with abnormal ECG results

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

  9. Echo/MUGA

    Number of participants with abnormal Echo/MUGA results

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

  10. Ophthalmologic findings

    Number of participants with abnormal ophthalmologic findings

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

Secondary outcomes (9)

  1. The immunogenicity of BAT8006

    Specification and quantification of ADAs or NAb

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

  2. Objective response rate (ORR)

    The proportion of subjects who achieved a confirmed response of complete response (CR) or partial response [PR]

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

  3. 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)

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

  4. 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

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

  5. 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

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

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

    Maximum concentration (Cmax)

    Measured: 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

  7. The pharmacokinetics (PK) profile of BAT8006（Time of Cmax (Tmax)）

    Time of Cmax (Tmax)

    Measured: 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

  8. The pharmacokinetics (PK) profile of BAT8006（Area under the curve (AUC)）

    Area under the curve (AUC)

    Measured: 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

  9. The pharmacokinetics (PK) profile of BAT8006（Terminal half-life (t½)）

    Terminal half-life (t½)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start31 Jan 2025
  3. Primary completion10 Mar 2026 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Why it stopped: Reconsideration of the subsequent international development of BAT8006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545617
Sponsor's protocol ID
BAT-8006-002-CR
Status last verified
Jan 2026
First submitted
31 Jul 2024
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BAT8006 for Injection in people with Platinum-resistant Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Bio-Thera Solutions.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose (MTD) and/or identify the recommended Phase 2 dose (RP2D) of BAT8006 (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06545617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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