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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT06994195
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Liposomal doxorubicin, Paclitaxel or Topotecan — DRUG
    Administration by intravenous infusion for a cycle of 4 weeks.

Study Details

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.

Key Dates

First listed
May 29, 2025
Start date
Aug 4, 2025
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-B01D1
    Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
  • Active Comparator: Investigator's choice of chemotherapy
    Participants receive Liposomal doxorubicin, Paclitaxel or Topotecan in the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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