A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07054567
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Pembrolizumab — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Bevacizumab — DRUG
    Administration for a cycle of 3 weeks.

Study Details

This Phase II study is a clinical trial to evaluate the efficacy and safety of BL-B01D1 + pembrolizumab dual therapy with or without bevacizumab (BL-B01D1 + pembrolizumab ± bevacizumab) in patients with recurrent or metastatic cervical cancer and endometrial cancer.

Key Dates

First listed
Jul 8, 2025
Start date
Aug 21, 2025
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BL-B01D1 + pembrolizumab ± bevacizumab
    Participants receive BL-B01D1 + pembrolizumab ± bevacizumab 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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