A Phase II Clinical Study 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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• The subject voluntarily participates in this study and signs the informed consent form;

• Age ≥18 years and ≤75 years;

• Expected survival time ≥3 months;

• ECOG performance status score of 0-1;

• Patients with recurrent or metastatic cervical cancer or endometrial cancer confirmed by histopathology and/or cytology;

• Archived tumor tissue samples from the primary or metastatic lesions within the past 3 years must be provided for PD-L1 and other testing;

• Must have at least one measurable lesion as defined by RECIST v1.1;

• Organ function levels must meet the requirements;

• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;

⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum or urine pregnancy test must be negative. Patients must not be lactating. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2027-12
Participants
Target number of participants: 206
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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