RecruitingPhase 3NCT06994195

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

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

384 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug (BL-B01D1, an antibody-drug conjugate) to the investigator's choice of chemotherapy in women with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer that has returned after prior treatment. **You may be eligible if...** - You are 18 or older with confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer - Your cancer has come back despite platinum-based chemotherapy (platinum-resistant recurrence) - You have received 1–3 prior lines of treatment and your cancer is progressing - You have at least one measurable tumor and good organ function (ECOG 0–1) - If your tumor tests positive for FRα, you must have already received mirvetuximab soravtansine **You may NOT be eligible if...** - You received chemotherapy or targeted therapy within the past 4 weeks - You have severe heart problems (ejection fraction below 50%) - You are pregnant or breastfeeding - Your cancer has unresolved serious side effects from prior treatment above grade 1 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGLiposomal doxorubicin, Paclitaxel or Topotecan

Administration by intravenous infusion for a cycle of 4 weeks.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06994195


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