Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06994195

A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)

Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-04-20

384

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

S

Sichuan Baili Pharmaceutical Co., Ltd.

Lead Sponsor

B

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial is a registered, phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with platinum-resistant recurrent epithelial ovarian cancer.

CONDITIONS

Official Title

A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent and follow study rules
  • Age 18 years or older
  • Expected survival of at least 3 months
  • Confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Previously treated with platinum-based therapy and confirmed platinum-resistant recurrence
  • Received 1 to 3 prior systemic anti-tumor therapies with disease progression or intolerance
  • For folate receptor-alpha positive patients, progression after mirvetuximab soravtansine treatment
  • Agree to provide tumor tissue samples from the last 3 years
  • Have at least one measurable lesion by RECIST v1.1 criteria
  • ECOG performance status of 0 or 1
  • Toxicity from previous treatments recovered to Grade 1 or less
  • No severe heart dysfunction; ejection fraction 50% or higher
  • Meet required organ function levels
  • Coagulation tests within defined normal limits
  • For premenopausal women, negative pregnancy test within 7 days before treatment and not breastfeeding
  • Use adequate contraception during and for 6 months after treatment
Not Eligible

You will not qualify if you...

  • Use of chemotherapy, targeted, or biological therapy within 4 weeks or 5 half-lives before randomization, or palliative radiotherapy within 2 weeks
  • Eligible for radical locoregional therapy for advanced or metastatic platinum-resistant disease
  • Previous frontline treatment with ADCs targeting topoisomerase I inhibitors or EGFR/HER3
  • History of severe heart or cerebrovascular disease
  • Unstable thrombotic events requiring treatment within 6 months before screening
  • Serious heart rhythm problems like prolonged QT, complete left bundle branch block, or uncontrolled arrhythmia
  • Active malignancy diagnosed within 3 years before randomization
  • Poorly controlled hypertension or poor glycemic control
  • Grade 1 or higher radiation pneumonitis or previous interstitial lung disease
  • Severe pulmonary disease affecting respiratory function
  • Active central nervous system metastases
  • Severe infections within 4 weeks or active lung infections within 2 weeks before randomization
  • Large or symptomatic fluid build-up not controlled
  • Tumor invading or surrounding major blood vessels
  • Serious unhealed wounds, ulcers, or fractures within 4 weeks before consent
  • Significant bleeding or bleeding tendency within 4 weeks before consent
  • Certain severe gastrointestinal conditions like inflammatory bowel disease or intestinal obstruction
  • Allergy to humanized antibodies or BL-B01D1 components
  • History of stem cell transplantation
  • HIV positive or active hepatitis B or C infection
  • Severe neurological or psychiatric illness
  • Use of other investigational drugs within 4 weeks before randomization
  • Planned or recent live vaccination within 28 days before randomization
  • Other conditions making participation unsafe or inappropriate as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

S

Sa Xiao, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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