NCT05990803

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.

Detailed description

Objective: To explore the efficacy of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer. To explore the safety and tolerability of BL-B01D1 monotherapy, SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination therapy.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	BL-B01D1	BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
DRUG	SI-B003	SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).

Timeline

• Start date: 2023-11-06
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-08-14
• Last updated: 2025-09-26

Locations

1 site across 1 country: China